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Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $74.5.
FSMA (Food Safety Modernization Act) requires organizations to assess risks, enact Preventative Controls to mitigate these risks and minimize Food Safety Hazards for consumers.
Speaker: Gina Reo | View Anytime | Duration: 60 Minutes | Price: $599.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must do it because the regulation requires it.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Pharmaceutical manufacturing sites continuously compete within the same company to maintain production volumes and avoid closures.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA's recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training is designed to revolutionize the way you work with Excel. Copilot is an AI-powered tool that enhances your Excel experience by automating complex tasks, providing intelligent suggestions, and improving overall efficiency. Whether you're dealing with large datasets, creating intricate formulas, or simply trying to streamline your daily workflow, Copilot is here to help.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Elevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365, Excel 2021 and Excel 2024 users.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In today's fast-paced and data-driven world, efficiency, accuracy, and innovation are more critical than ever. This session will introduce you to the seamless integration of ChatGPT with Excel, showing how AI can dramatically boost your spreadsheet capabilities.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today's busy world, we are sometimes overwhelmed with huge amounts of data, sometimes that data can come from more than one table, or even more than 1 data source. Trying to make sense of this data can be an overwhelming task.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today's world, there are tons of data to manage. Data is coming from many different sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
NOTE: This course is not appropriate for Mac or Excel for Web users as the functionality does not exist on those platforms.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data?
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
As global trade undergoes profound changes, companies and governments must look beyond today's tariff challenges and prepare for a more complex, uncertain future.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Trade deals and tariff negotiations are key tools governments use to influence economic outcomes, build alliances, and protect domestic industries.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training provides detailed, practical insight into navigating tariff regulations, focusing on legal obligations and the compliance processes that international businesses must follow.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tariffs are more than just taxes on imports-they are instruments of trade policy that influence the behavior of nations, companies, and consumers.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will explore the best practices and strategic approach for evaluating Excel spreadsheets used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In today's fast-paced and data-driven world, efficiency, accuracy, and innovation are more critical than ever. This session will introduce you to the seamless integration of ChatGPT with Excel, showing how AI can dramatically boost your spreadsheet capabilities.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In today's busy world, we are sometimes overwhelmed with huge amounts of data, sometimes that data can come from more than one table, or even more than 1 data source. Trying to make sense of this data can be an overwhelming task.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today's world, there are tons of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This webinar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today's busy world, we are sometimes overwhelmed with huge amounts of data, sometimes that data can come from more than one table, or even more than 1 data source. Trying to make sense of this data can be an overwhelming task.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today’s world, there are tons of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This webinar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management. Others are targeted to health care providers as tools to improve and facilitate the delivery of patient care.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will examine the CAPA regulations, 21 CFR 211.198 (Pharma), 21 CFR 820.100 (Devices), Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and 21 CFR 822.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Section 522 is implemented in 21 CFR 822.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipmnet, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training provides detailed, practical insight into navigating tariff regulations, focusing on legal obligations and the compliance processes that international businesses must follow.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Tariffs are more than just taxes on imports-they are instruments of trade policy that influence the behavior of nations, companies, and consumers.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View DetailsAI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Assessment of the cause for a non-compliance is a structured series of branching questions.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Assessment of the cause for a non-compliance is a structured series of branching questions.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Assessment of the cause for a non-compliance is a structured series of branching questions.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, we will examine the overall structure of design control as it relates to the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.
Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Learn key assumptions in a projection and how to assess validity, the value of a downside-most likely projection to stress test the assumptions
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
What complicates survival in this current economic environment is the combination of elevated inflation and possible recession
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
One of the most basic analytical and underwriting tools a banker must have is the ability to determine whether a borrower can repay its short-term borrowings based on the financial information available
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today’s world of evolving technologies and businesses, financial organizations are taking on increasing levels of risk.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ratio analysis helps lenders and analysts to determine a borrower’s operating performance (profitability and productivity) and financial condition (liquidity, leverage, solvency) by rendering the financial statements into ratios.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Several new principles warrant review to understand how they will affect both borrowers and lenders-new GAAP for revenue recognition, lease capitalization, current expected credit losses (CECL) as well as changes to not-for-profit financials.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The regulatory agencies and investors expect bank and other organizations extending credit to possess a strong credit culture. This session will explain what a credit culture is, how to implement it, and how to maintain a strong credit culture.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Both lenders and borrowers like to to use EBITDA as proof of repayment ability, but as noted earlier, it overestimates repayment ability.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The MENA region suffers from a Drug & Device Lag, meaning innovative products typically do not reach the market for 10+ years, after they are approved and launched in the U.S. or EU. Because of this, there exists significant opportunity for U.S. and EU developed products, if the regulatory hurdles can be navigated
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mastering Power-User techniques in Microsoft Word is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customized practical PowerPoint example is provided with slides in sequence for each question posed to DeepSeek for demonstration and “hands-on” practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customized practical Excel example is provided with slides in sequence for each question posed to DeepSeek for demonstration and “hands-on” practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customized practical PowerPoint example is provided with slides in sequence for each question posed to ChatGPT for demonstration and “hands-on” practice by attendees
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In today's world, there are a ton of data to manage. Data is coming from many different sources.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Post-Market Surveillance (PMS) and Vigilance Reporting for Medical Devices and Combination Products are critical components of regulatory compliance, ensuring ongoing patient safety and product effectiveness after market approval.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This 60-minute webinar on GMP Compliance for Biopharmaceuticals and Cell & Gene Therapy Products provides a comprehensive overview of regulatory expectations, quality management principles, and industry best practices for ensuring compliance in these highly specialized fields.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
A risk-based approach to supplier qualification in GMP manufacturing ensures that suppliers are evaluated, selected, and monitored based on their potential impact on product quality and patient safety.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Good Documentation Practices (GDP) are a critical requirement in both Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) environments, ensuring the accuracy, integrity, and reliability of records that support regulatory compliance.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continue to evolve, posing ongoing challenges for medical device and diagnostic manufacturers. With 2025 bringing critical deadlines, regulatory updates, and new compliance expectations, companies must stay ahead to ensure smooth market access and adherence to stringent requirements.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The FDA’s transition from the Quality System Regulation (QSR) to ISO 13485 marks a significant shift in medical device regulatory compliance, aligning U.S. quality management requirements with global standards.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Life sciences projects are highly complex, requiring a strategic approach to managing regulatory compliance, cross-functional teams, budgets, and timelines.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Effective budgeting and resource allocation are critical to the success of clinical trials, ensuring financial sustainability while maintaining compliance and efficiency.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Managing global teams in the life sciences sector requires a strategic approach to leadership, communication, and regulatory alignment.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Regulatory submissions for drug development require precise project scheduling to meet critical milestones and ensure timely market entry.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Medical device submissions in the US and EU require precise project scheduling to ensure timely regulatory approvals.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Effective Standard Operating Procedure (SOP) writing and management are critical for ensuring regulatory compliance and operational consistency.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
A compliant training program is essential for ensuring personnel in GMP, GCP, and quality system-regulated environments are knowledgeable, competent, and audit-ready.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Effective technical writing is critical for successful regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Premarket Approval (PMA) submissions.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar, Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping, provides a comprehensive understanding of regulatory requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar, Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements, provides a comprehensive overview of data integrity principles, regulatory expectations, and compliance strategies in pharmaceutical and clinical environments.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ensuring that personnel are properly trained is critical for maintaining compliance with Quality System Regulations (QSR) and ISO standards in regulated industries such as medical devices and pharmaceuticals.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Data protection and privacy is an important issue this day and age for the public.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training is designed to revolutionize the way you work with Excel. Copilot is an AI-powered tool that enhances your Excel experience by automating complex tasks, providing intelligent suggestions, and improving overall efficiency. Whether you're dealing with large datasets, creating intricate formulas, or simply trying to streamline your daily workflow, Copilot is here to help.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Elevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365, Excel 2021 and Excel 2024 users.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In today’s fast-paced and data-driven world, efficiency, accuracy, and innovation are more critical than ever. This session will introduce you to the seamless integration of ChatGPT with Excel, showing how AI can dramatically boost your spreadsheet capabilities.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling. Discover the power of visual data representation to transform complex numerical information into compelling, insightful visual narratives.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use DEEPSEEK for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of DEEPSEEK for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use DEEPSEEK for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of DEEPSEEK for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Alan M Golden | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This easy to follow demonstration clearly explains how to effectively post ChatGPT questions on more advanced Excel topics and extract more accurate responses.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This easy to follow demonstration clearly explains how to effectively post ChatGPT questions on more advanced Excel topics and extract more accurate responses.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 90-minute webinar will begin with an introduction to the fundamentals of project management, tailored specifically for those who may not have formal training in the field.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Data protection and privacy is an important issue this day and age for the public.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Since Compliance Officers have direct contact with all parts of the business, it's essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The topic delves into the critical interplay between human factors, design processes, and patient safety within the realm of healthcare technology. It begins by elucidating the multifaceted nature of human errors, encompassing cognitive, perceptual, and physical aspects, and underscores their potential impact on patient well-being.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 90-minute webinar will delve into the fundamental aspects of HFE, emphasizing its pivotal role in enhancing safety, efficiency, and overall user experience within the medical device landscape.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In today's data-driven world, having a strong command of Excel is essential, and understanding the Data Analysis Expressions (DAX) formula language is the key to unlocking the true potential of Excel's Power Pivot and Data Model features.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use ChatGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will explore the best practices and strategic approach for evaluating Excel spreadsheets used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The purpose of this workshop is to use the features of the data ribbon and the PivotTable of Excel for what we call datamining.
Speaker: Isaac Gottlieb | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control. We will discuss how to determine the level of impact assessment needed for what type of changes and how to base this decision on risk.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This workshop is about understanding what is behind the Monte Carlo Simulation.
Speaker: Isaac Gottlieb | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 90-minute webinar is designed to provide professionals across various industries with a comprehensive understanding of the critical intersection between effective technical writing, regulatory compliance, and copyright considerations.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today's world, there are a ton of data to manage. Data is coming from many different sources.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
Speaker: Michael Esposito | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industrial systems worldwide.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Unlock the full potential of Excel with our deep-dive webinar into the newly introduced GROUPBY and PIVOTBY functions.
Speaker: Abdelrahman Abdou | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dive deeper into Excel Pivot Tables with our upcoming webinar, designed for those who are already familiar with the basics and ready to explore more sophisticated functionalities.
Speaker: Abdelrahman Abdou | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This comprehensive three-hour virtual seminar, titled "Mastering AI Integration in Project Management: Leveraging ChatGPT for Enhanced Efficiency and Compliance in FDA-Regulated Industries," is designed to provide project management professionals with a thorough understanding of the practical applications of AI tools like ChatGPT.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This 90-minute webinar is designed to provide project management professionals with comprehensive insights into the practical applications of AI tools like ChatGPT.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is not possible to present a complete treatment of project management in the span of 4-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 90-minute webinar will begin with an introduction to the fundamentals of project management, tailored specifically for those who may not have formal training in the field.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar is broken into two phases. Phase one will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The course provides a concise overview of how accountants can use ChatGPT to assist with communications involving intricate and often sensitive topics that require a deep understanding of both financial principles and human resource policies. These conversations can range from budgeting and compensation to ethical considerations and regulatory compliance.
Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
This seminar is broken into two phases. Phase One corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course offers an in-depth look into Generative AI and its transformative impact on the accounting profession. At the core of Generative AI are technologies that can literally "see, speak, hear, write, and create" in multimodal contexts.
Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In today's data-driven landscape, the fusion of Excel's computational might with ChatGPT's intelligent querying transforms ordinary accounting tasks into dynamic, insightful financial analyses. This specialized masterclass unveils the power behind integrating Excel and ChatGPT, aimed at accountants, financial analysts, and business professionals eager to unlock new levels of efficiency and creativity in their financial workflows.
Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance on how to implement and maintain the desired level of credit risk management with practical tools and techniques.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 90-minute webinar will delve into the fundamental aspects of HFE, emphasizing its pivotal role in enhancing safety, efficiency, and overall user experience within the medical device landscape.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course is designed to teach learners how to use CHATGPT and other AI tools for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
With AI, we need to understand the risks and opportunities it presents. The risk can be high, but prevention is the key. With every technology, there can be element of good and evil. Within financial services. AI can be applied to identify unusual activity, show inconsistent data, remove manual efforts, improve collaboration, and offer a quick and efficient means to review vast amounts of information.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
“From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA” is a comprehensive training session designed to provide participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating dietary supplements.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course offers an in-depth look into Generative AI and its transformative impact on the accounting profession. At the core of Generative AI are technologies that can literally "see, speak, hear, write, and create" in multimodal contexts.
Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The course provides a concise overview of how accounting professionals can leverage ChatGPT, OpenAI's powerful language model, to innovate and enhance their business advisory services. In plain language the presentation integrates theory and practice, and demonstrates how various enterprise evaluation methodologies can be applied in combination with ChatGPT to sharpen your business analysis and increase your organization’s efficiency, profitability, and growth
Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today's data-driven landscape, the fusion of Excel's computational might with ChatGPT's intelligent querying transforms ordinary accounting tasks into dynamic, insightful financial analyses. This specialized masterclass unveils the power behind integrating Excel and ChatGPT, aimed at accountants, financial analysts, and business professionals eager to unlock new levels of efficiency and creativity in their financial workflows.
Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The course provides a concise overview of how accountants can use ChatGPT to assist with communications involving intricate and often sensitive topics that require a deep understanding of both financial principles and human resource policies. These conversations can range from budgeting and compensation to ethical considerations and regulatory compliance.
Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ultimately costing principles, such as the causality principle, must be converted into practical practices with supporting tools.
Speaker: Gary Cokins | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term. We also give a brief overview of how sustainability has been wrongly tackled in the past.
Speaker: Willy Vandenbrande | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details.jpg "Dr. Kimberly N. West - Complinace4All")
In today's digital world, artificial intelligence (AI) is making waves in education. But with all the talk of AI-powered this and AI-powered that, you might be wondering, "What does that even mean for me as a teacher?"
Speaker: Dr. Kimberly N. West | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI for Project Managers: Boost Your Skills and Supercharge Your Projects
Speaker: Dr. Kimberly N. West | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mastering AI Governance: Leading the Way Responsibly
Speaker: Dr. Kimberly N. West | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this webinar, we take an in-depth exploration of how AI, particularly ChatGPT, can revolutionize Excel usage and go beyond traditional spreadsheet functionalities. Attendees will gain valuable insights into the following key topics:
Speaker: Alan Murray | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several functions inside and outside of the company.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
People and communications skills are very important in dealing with customers, but have little connection to doing good lab work. This webinar points out some approaches and skills to connect the two areas.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference. Major emphasis will be upon risk management in accordance with ISO 14971 (-:2019), which currently has only casual reference in 820.30. The FDA views risk management as an “essential systematic practice” to ensure that devices are safe and effective. If the proposed rule is finalized, it will enhance some parts of ISO 13485. Device manufacturers will need to enhance risk management procedures for specific devices and in all other areas of their businesses to align with the QMSR. Design Control (ISO 13485 7.3 Design and Development) will have limited application to Class I devices, but fully involve Class II and III (US classifications) as is currently done in the US but not the EU.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The feeling is sometimes created that technology itself leads the waves of change.
Speaker: Willy Vandenbrande | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals”
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Your data is only as good as the information you can derive from it. Power Pivot enables you to gain better business insights and make more informed business decisions.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Become an Excel Hero in your organization! Make yourself indispensable. If these are your goals, having a good understanding of Excel's Logic functions is critical. It will help you with scenarios like these:
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Elevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365 and Excel 2021 users
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
During this webinar we will provide information on the backgrounds of FDA employees, how FDA employees are trained, how they interact with the regulated industry.
Speaker: Larry Stevens | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Going “beyond the basics” Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Plan and initiate your projects with confidence, knowledge and consistency.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Understand and apply the power of linking techniques within Excel and other key MS Office applications to boost productivity and efficiency for you and your organization.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
PivotTables are reputed to be the most powerful “in-built” feature in Excel aside from Macros.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
China's Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China's NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device.
Speaker: Robert J. Russell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling. Discover the power of visual data representation to transform complex numerical information into compelling, insightful visual narratives
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Impress your boss. Impress your colleagues. Turn drab into fab. Tell your story with awesome charts in Excel. This webinar will equip you with the knowledge you need to turn your numerical data into a set of engaging, attention-grabbing and easy-to-understand visuals!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today's world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Since Compliance Officers have direct contact with all parts of the business, it’s essential that they have the necessary tools to succeed and help shift the compliance culture of an organization. This webinar is geared towards Compliance Officers in an organization that deal with internal stakeholders. We will discuss ways to train compliances officers effectively and how to go about it.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Since Compliance Officers have direct contact with all parts of the business, it’s essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
During this webinar, we go through each step and discuss best practices to create and implement a successful compliance training program
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This session describes how to solve costly business problems and add real value to organizations by applying the best of Lean Six Sigma with enhanced score-carding within an Operational Excellence system.
Speaker: Forrest Breyfogle | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Effective Key Performance Indicator (KPI) metric management in an organization is critical; however, there are issues with traditional metric reporting and its accompanying goal-setting practices.
Speaker: Forrest Breyfogle | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation is a dynamic and comprehensive 90-minute webinar designed to empower researchers, students, and professionals in the life sciences field with essential skills for effective written communication.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 90-minute webinar is designed to provide professionals across various industries with a comprehensive understanding of the critical intersection between effective technical writing, regulatory compliance, and copyright considerations.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 90-minute webinar delves into the critical intersection of post-market surveillance and project management, providing professionals across industries with comprehensive insights into ensuring long-term success.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many virtual companies incorrectly think they don't need SOPs or GMP training.
Speaker: Arvilla Trag | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
To gain a practical “hands-on” understanding of how to efficiently create, manage and run Macros in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables are arguably the most popular analytic tool.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tables are a powerful Excel functionality to streamline many data management functions.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Understanding effective and accurate task management, durations, linking and scheduling are essential to start your projects correctly and minimise major adjustments, delays and cost impacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you work for any firm that manufactures products regulated by FDA, you very likely will experience an FDA inspection.
Speaker: Larry Stevens | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term.
Speaker: Willy Vandenbrande | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions. It will explain how cyber risks are identified and mitigated.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Understanding effective and accurate task management, durations, linking and scheduling are essential to start your projects correctly and minimise major adjustments, delays and cost impacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables are arguably the most popular analytic tool.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Engaging and professional new features help you dazzle your audience with a wide range of captivating options.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Business continuity planning is crucial for contract manufacturers operating in the life sciences industry
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In today's fast-paced operational environments, organizations face challenges related to human performance, human error, and mental load. This comprehensive two-hour training program aims to equip participants with the knowledge, skills, and strategies to reduce performance failures in operations.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tables are a powerful Excel functionality to streamline many data management functions.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human Error Reduction Techniques for Floor Supervisors
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar begins with an introduction to the regulatory landscape governing contract manufacturing operations. The presenter, an industry expert with extensive knowledge of FDA and European regulatory guidelines, sets the stage by highlighting the importance of compliance and its impact on product quality, patient safety, and market access.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 3-Hour seminar covers the details of the Regulatory Requirements for a wide range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices, and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Clinical trial project management is a complex and dynamic process that requires careful planning, coordination, and communication among stakeholders.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. The project manager is responsible for creating a comprehensive quality management plan, implementing quality control procedures, and identifying areas for continuous improvement. By doing so, they ensure that the final product meets the quality objectives and customer requirements.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel’s 500+ functions represent a potent set of power tools that simplifies many different kinds of formulas and gives you a huge number of computational possibilities.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance on how to implement and maintain the desired level of credit risk management with practical tools and techniques.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
Speaker: Karl Nobert | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is not possible to present a complete treatment of project management for this industry in the span of 90 minutes. It is however possible to focus on those most critical project management aspects that are critical to the success of any project within biotechnology and the biomedical industry in general.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the "vaccine for mistakes," Training is as good as its effectiveness.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Due to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document", and 2) "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and 3) "Postmarket Management of Cybersecurity in Medical Devices" Draft.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In addition to producing a Trial Master File (TMF), companies engaged in the conduct of human clinical trials must adhere to FDA’s requirements for Computer System Validation (CSV) and Data Integrity. In addition, they must adhere to specific government regulatory requirements. Certain documents, content, and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Speaker: Carolyn Troiano | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel’s 500+ functions represent a potent set of power tools that simplifies many different kinds of formulas and give you a huge number of computational possibilities.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Clinical trial project management is a complex and dynamic process that requires careful planning, coordination, and communication among stakeholders.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. The project manager is responsible for creating a comprehensive quality management plan, implementing quality control procedures, and identifying areas for continuous improvement. By doing so, they ensure that the final product meets the quality objectives and customer requirements.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Effective project management is essential in the development of In Vitro diagnostics. It ensures the timely completion of the project, and the efficient use of resources, coordination of teams, risk management, and quality management.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is important for a project manager to understand how the project management process integrates into drug development because drug development is a complex and highly regulated process that involves various stages, including discovery, pre-clinical development, clinical development, regulatory submission, and post-marketing surveillance.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the "vaccine for mistakes," Training is as good as its effectiveness.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, on a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is intended for Pet Food Industry Representatives, Manufacturers, Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, Market Watchers, and Investment Analysts seeking an understanding of how pet food is regulated in the United States.
Speaker: Karl Nobert | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Bioassays are used to demonstrate that a biological product performs per the stated function and potency. Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tables are a powerful Excel functionality to streamline many data management functions.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Skills to effectively manage, present and communicate data are now vital in the competitive financial and business analysis fields and offer vast opportunities to expand accounting client services and career paths.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Emails are a core business communication tool. The speed and volume of email have dramatically changed business communication. The not-so-old standards for professional correspondence have changed and will continue to do so. Employees need to know the best strategies to communicate effectively. An effective business email is easily understood, but it is not so easily written.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good leaders walk the talk, but they also “write right”. They know how to say in a few words what needs to be said in crisp, clear language. The road to bad communication is paved with good intentions but poor construction. Readers know when subjects and verbs don’t agree when punctuation misses the point when words don’t fit, and content is confusing. In this session, learn how a few basic rules on grammar, punctuation, and usage can improve business written communications with clearer, more succinct content.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin with an explanation of the process and how it originally conflicted with all regulatory bodies worldwide and how it now can be applied, with minor adjustments, to counter those original difficulties. The webinar will also discuss when the process should be used, how it should be staffed, and the process for its use.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View DetailsNo matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.
View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how users interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. Required documentation will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to devise users.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.
Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Software and related hardware design, development, verification, and validation are difficult to manage, document and control. This presentation focuses on the verification and validation planning and execution of software, after basic developmental testing and debugging. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel at the introductory level.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Skills to effectively manage, present and communicate data are now vital in the competitive financial and business analysis fields and offer vast opportunities to expand accounting client services and career paths.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables is arguably the most popular analytic tool.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real-time. This table empowers the user to view and analyze large amounts of information.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will benefit all pharmaceutical & biotech professionals who work in QA, Compliance, Regulatory Affairs, Purchasing, and Supply Chain. This seminar will cover the importance of vendor qualification programs, and how well these programs can be implemented in a pragmatic & compliant manner.
Speaker: Nada Kuganathan | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by defining value stream mapping and the key terms that comprise the VSM process. The purpose of VSM, important to participant focus, will also be discussed.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for the promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume you're talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this training, you’ll learn some powerful tips, tricks, and shortcuts to help you become more productive in your use of Excel.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armoury and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it’s flexibility and the fact that most people have it installed on their computer.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you manufacture FDA-regulated drugs, devices, biologics, combination products, dietary supplements, or cosmetics the underlying reason FDA will inspect your facility is to determine if you are in control of all aspects of the operation. It is not enough to have SOPs that state what is supposed to happen. FDA starts with your products and then works backward to determine if all the pieces are in place. For contract manufacturers, the challenge grows exponentially as the number of clients and products increases.
Speaker: John Misock | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Lynn Fountain | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Good leaders walk the talk, but they also “write right”. They know how to say in a few words what needs to be said in crisp, clear language. The road to bad communication is paved with good intentions but poor construction. Readers know when subjects and verbs don’t agree when punctuation misses the point when words don’t fit, and content is confusing. In this session, learn how a few basic rules on grammar, punctuation, and usage can improve business written communications with clearer, more succinct content.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Verification and validation requirements have always been part of the US FDA’s GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Microsoft Outlook is a powerful productivity tool and if you are using it only for email and for keeping track of meetings and appointments, about 80-85% of the power of Outlook is unused. You paid a great deal for the privilege of using Microsoft Outlook - why not wring every dollar you can out of it?
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Do you remember when hand-written letters or typed letters was the main means of communication? If so, you may also remember how glorious it was to send information and have immediately received via the fax machine.
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Prioritizing is a fundamental time management principle and, in this webinar, you are taught the principles of prioritizing and how to work check off work right in your Inbox.
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances. This happens because FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment using real-world data to improve performance. Thus the field version of the software is no longer the validated approved version.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
In this seminar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.
Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The use of statistics in clinical trials insures a valid and robust study which minimizes bias in assessing the efficacy of new drug treatment or medical devices.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Bioassays are used to demonstrate that a biological product performs per the stated function and potency.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.
Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.
Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel's non-charting tools.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don’t, you’re missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The subject of this webinar is building the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The first step in catapulting your career ahead of your competitors is fully to use Microsoft Outlook.
Speaker: Karla Brandau | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The use of statistics in clinical trials insures a valid and robust study which minimizes bias in assessing the efficacy of new drug treatment or medical devices.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many laboratories have successfully developed and implemented a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.
Speaker: Michael Brodsky | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet, is still a common source of 483 and Warning Letter observations.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
Speaker: Joy McElroy | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.
Speaker: Joy McElroy | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The term, Incoterms®, is an abbreviation for International Commercial Terms.
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified.
Speaker: Steven Wachs | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The use of statistics in clinical trials insures a valid and robust study which minimizes bias in assessing the efficacy of new drug treatment or medical devices.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
You need to eradicate racism in the workplace and promote unity. Learn how to build an inclusive and equitable organization, ensure fairness for all employees, candidates, customers, and other stakeholders.
Speaker: Robert Greene and Marques Ogden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Recently, OSHA issued over 40,000 citations for safety violations in the workplace. In one example, a HVAC company was fined over $1.2 million for recordkeeping violations.
Speaker: Deidre Tate | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.
Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
FDA’s import and export programs are complex, detailed and undergo changes without notice to the public.
Speaker: Casper Uldriks | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.
Speaker: Adriaan Fruijtier | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Statistics is a useful decision making tool in the clinical research arena.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits. Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology.
Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.
Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation.
Speaker: Danielle DeLucy | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.), and the common practice.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Due to the growth of electronic records and electeronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integrity in this changing environment.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Due to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document”, and 2) "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and 3) "Postmarket Management of Cybersecurity in Medical Devices" - Draft.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Learn how to quickly spot violations in the workplace and how to correct them to OSHA standards by attending this webinar.
Speaker: Deidre Tate | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes. The United States-Mexico-Canada Agreement (USMCA), commonly referred to as the "New NAFTA," is essentially “NAFTA 2.0".
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.
Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.
Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel expert David Ringstrom, CPA, shows you how to implement internal control features within your Excel spreadsheets in this enlightening presentation. David uses a simple invoice form as a teaching aid to present various ways to control users' actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. David demonstrates every technique at least twice first, on a PowerPoint slide with numbered steps, and second, in Excel 2016. He'll draw to your attention any differences in Excel 2013, 2010, or 2007 during the presentation as well as in his detailed handouts. David also provides an Excel workbook that includes most of the examples he uses during the webcast.
Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
For years the IRS has struggled with the independent contractor and tax collection.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This 60-minute webinar will cover the proposed FDA traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls.
Speaker: John Ryan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The circumstances surrounding the coronavirus are continuing to develop each day, and with the rapid-fire nature of the modern media, details vary from broadcast to broadcast, leaving the audience in fear and confused as to what next steps they should take. Having a plan is the best course of action, and with the changing national condition, employers are feeling the pressure of growing concern.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries.
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $95.
The term, Incoterms®, is an abbreviation for International Commercial Terms.
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Is managing your Inbox and digging out from an avalanche of emails a full time job? Then sign up for this webinar and learn how to survive the heavy load of tasks and the constant stream of trivia that arrives via email.
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $95.
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $95.
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this informative webcast, Excel expert David H. Ringstrom, CPA, introduces you to the concept of Microsoft Excel dashboards.
Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $95.
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The FDA’s expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: $95.
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $95.
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The global pandemic is here and has caused us to change and adapt our working and personal lives.
Speaker: Vicki M. Lambert | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Do you remember when hand-written letters or typed letters was the main means of communication? If so, you may also remember how glorious it was to send information and have immediately received via the fax machine.
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
In a rare show of bipartisanship, the Families First Coronavirus Response Act (FFCRA) was signed into law on March 18, 2020.
Speaker: Diane L. Dee | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
According to Jonathan Spira, interruptions cost the US economy almost $1 trillion annually, and eat up to 28 billion hours each year.
Speaker: Rhonda Scharf CSP - HoF | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Many employers struggle to gather information during witness interviews in investigations. Many employees for a variety of reasons are reluctant to be involved and can be less than forthcoming.
Speaker: Teri Morning | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
When we think of workplace investigations, the most common thought is that of investigating harassment complaints.
Speaker: Dr. Susan Strauss | View Anytime | Duration: 2 Hours | Price: $235.00 | View Details
Sounds pretty simple, doesn't it? When you do it right, Dealing With Difficult People drastically improves your life as you improve your working relationships with people who challenge you to the limits of your patience (yes, even the ones who make you tear your hair out - literally!).
Speaker: Rhonda Scharf CSP - HoF | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Negative and difficult people are toxic and can ruin our day. Learn successful strategies and tips for building a positive, productive workplace by knowing WHAT to focus on to move the conversation forward, HOW to effectively respond, and WAYS to manage the impact of their behaviour.
Speaker: Beverly Beuermann-King | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
This webinar will give you all the tools you need to start your Exit Interview program or improve the one you have. It isn't rocket science but there are best practices and considerations for doing them well. Our intent is to get you up to speed as quickly and effectively as possible.
Speaker: Bob Verchota | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
The new Families First Coronavirus Response Act takes effect April 2, 2020 and with it comes temporary requirements that impacts employers with less than 500 employees.
Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
In this webinar we will learn the reasons onboarding is important today. We will learn that the terms orientation and onboarding are not interchangeable. We will learn that orientation is in reality just one step in the onboarding process. We will learn that the onboarding process begins before the hire is made.
Speaker: Michael D. Haberman | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Prioritizing is a fundamental time management principle and, in this webinar, you are taught the principles of prioritizing and how to work check off work right in your Inbox.
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Improving employee engagement can have dramatic effects on the organization's bottom line. Engaged employees are significantly more productive and less likely to leave.
Speaker: Dr. B. Lynn Ware | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Though there has been a recent trend toward employers offering remote working and telecommuting arrangements, having a majority of your workforce working from home can be daunting when leaders and managers have firm deliverables and deadlines to meet.
Speaker: Dr. B. Lynn Ware | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.
Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The new Families First Coronavirus Response Act takes effect April 2, 2020 and with it comes temporary requirements that impacts employers with less than 500 employees.
Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Though there has been a recent trend toward employers offering remote working and telecommuting arrangements, having a majority of your workforce working from home can be daunting when leaders and managers have firm deliverables and deadlines to meet.
Speaker: Dr. B. Lynn Ware | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
This is sessions provides current updates and information on the fast developing environment around the Coronavirus in the workplace.
Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
This is sessions provides current updates and information on the fast developing environment around the Coronavirus in the workplace.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The circumstances surrounding the coronavirus are continuing to develop each day, and with the rapid-fire nature of the modern media, details vary from broadcast to broadcast, leaving the audience in fear and confused as to what next steps they should take.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS).
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $95.
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA issued a guidance document covering GMP requirements for Phase 1 products.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence.
Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Analyzing strengths, weaknesses, opportunities, and threats through a SWOT Analysis is a common tool for strategic planning for businesses, business units, departments, or projects.
Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: $95.
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.
Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA regulates both finished dietary supplement products and dietary ingredients.
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence.
Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $95.
This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.
Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This course is essential for IVD Medical Device companies interested in ensuring their software enabled medical Devices or Software as an IVD Medical Device is compliant to the new Software requirements in the IVDR 2022 regulations avoiding revenue interruptions that can result from failed unannounced audits.
Speaker: Nancy Knettell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Laboratory Practices (GLPs), CFR part 58 is a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.
Speaker: Joy McElroy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.
Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $170.
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence.
Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.
Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.
Speaker: Todd B. Graham | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $95.
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations.
Speaker: Michael Esposito | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.
Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.
Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
cGMP pharmaceutical water systems require specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation to become available for pharmaceutical manufacturing of products for sale.
Speaker: Peter Vishton P.E. | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This presentation focuses on the role, skills, organizational opportunities, and the benefits of an independent audit group to advise senior management on the true causes of complex situations. Although the typical setting would be in larger multi-national companies, this role can be sized to meet the needs of all companies, especially when the situations will cross national, divisional, and organizational boundaries.
Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples
Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.
Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:
Speaker: Wayne Taylor | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Price: $190.00 | View Details
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Many laboratories have successfully developed and implementied a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.
Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples
Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.
Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Are you responsible for payroll or employer tax withholding compliance? Or maybe you were recently hired or promoted into the payroll department. During your indoctrination you are surprised at all the interesting things to do and how important this role is to the success of the company.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF including its derivative documents, the DMR and DHR.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $95.
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course provides a practical approach that will allow you to understand human behavior in the workplace, to assess your current human reliability situation, and support human error reduction efforts at your site.
Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This webinar will cover all aspects of testing to ensure that a computer system regulated by FDA "does what it purports to do," as per the guidance on computer system validation (CSV) from FDA, first issued in 1983.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $95.
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel's non-charting tools.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs.
Speaker: Joy McElroy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.
Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
The webinar will include the following critical information you will need:
Speaker: Todd B. Graham | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The US Government regulates the export of information, commodities, technology, and software considered important to US national security, economic competition, and foreign policy.
Speaker: Douglas Cohen | View Anytime | Price: $190.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
How well you communicate that information is critical to getting management's acceptance of your findings and their agreement with your recommendations.
Speaker: Jonnie T. Keith | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM.
Speaker: Steven Laurenz | View Anytime | Price: $190.00 | View Details
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible.
Speaker: Prof. Dr. h.c. Frank Stein | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course will give an introduction into the Medical Device Single Audit Program (MDSAP).
Speaker: Prof. Dr. h.c. Frank Stein | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.
Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples
Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records
Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar details the regulation and how it applies to computerized systems.
Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Regulation proposals of the European Commission
Speaker: Salma Michor | View Anytime | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.
Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients.Human error is a frequent occurrence in pharmaceutical manufacturing.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.
Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.
Speaker: Michael Esposito | View Anytime | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.
Speaker: John N. Zorich | View Anytime | Price: $190.00 | View Details
Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:
Speaker: Wayne Taylor | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.
Speaker: Thomas Bento | View Anytime | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For many people the holy grail of organization is a world where email overload doesn't exist and where all those sticky notes and paper notepads are magically replaced by a digital paperless system. Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality.
Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos. With an abundance of features and versions for desktop and mobile, there's really no excuse not to be organized. Or so the theory goes.
Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will learn the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
The logistics industry is huge, worldwide and critical to our global economy. The industry consists of transportation, warehousing, logistics and technology companies that move goods (physical assets) from producers to consumers.
Speaker: Joe Lynch | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Once a block is written to the blockchain it can't be altered by anyone. If somebody tries to introduce a fake transaction into the ledger, he can only do so by adding it to all copies of distributed ledger (which is not possible, as every block is cryptographically linked with previous and next block) else that transaction is spotted and will be removed. Before a record is written to the blockchain, it needs to be verified and this is done by special nodes (computers) called miners.
Speaker: Joe Lynch | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:
Speaker: Dr. Shuguang Huang | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 brings substantial changes to the rules around personal data and its use. While it aims at building on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.
Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.
Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.
Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:
Speaker: Wayne Taylor | View Anytime | Duration: 90 Minutes | Price: $95.
Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:
Speaker: Wayne Taylor | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products.
Speaker: Emil W Ciurczak | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.
Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Price: $190.00 | View Details
The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.
Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Price: $190.00 | View Details
Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar will provide the regulatory requirements (US) of 21 CFR Section 820.50 (Purchasing Control) for the Medical Device industry and provide you with examples. It will furnish details on what should your Purchasing/Supplier Control management system address.
Speaker: Vanessa Lopez | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
This webinar will break down recommendations included in the guidance document and provide some practical solutions to each.
Speaker: Tim Lombardo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.
Speaker: Derk Yntema | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $170.
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Bringing pharmaceutical products to market in China has become much easier for foreign companies. The Chinese FDA (CFDA), now renamed as CNDA, recently made a series of significant changes to the marketing authorisation regulations by issuing a large number of guidelines and opinions (in Chinese).
Speaker: Yingying Liu | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This course will teach how to comply to 21 CFR Part 820.70(i) and effectively implement a software validation program for medical devices, meeting the FDA requirements and produce a safe product. We will explain the role of Risk Management in Non-Product Validation. How software requirements are used in validation will be described.
Speaker: Thomas Bento | View Anytime | Price: $190.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Price: $340.00 | View Details
The single most important aspect of any project is the defining of all the tasks that must be performed to accomplish the project's objectives.This definition is called the work breakdown structure.
Speaker: Charles H. Paul | View Anytime | Price: $190.00 | View Details
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct, or else, FDA's entry requirements with detain your product. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.
Speaker: Casper Uldriks | View Anytime | Duration: 3 hours | Price: $340.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.
Speaker: Laura Brown | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This course delves further into the expectations of COSO Principle Eight.We discuss and evaluate the COSO anti-fraud guide released in September 2016 and evaluate how the Fraud principles relate to the COSO 2013 principles.We also examine actions that organizations, management, and employees should be aware of in relationship to fraud.
Speaker: Lynn Fountain | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.
Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".
Speaker: John N. Zorich | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.
Speaker: Vanessa Lopez | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.
Speaker: Salma Michor | View Anytime | Price: $190.00 | View Details
Regulation proposals of the European Commission
Speaker: Salma Michor | View Anytime | Price: $190.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 3 Hours | Price: $170.
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.
Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.
Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
This webinar details the regulation and how it applies to computerized systems.
Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Congress recognized that FDA struggles with software regulation. So, Congress removed some software out of FDA's jurisdiction. Now FDA must revise its premarket and postmarket software regulatory approach, including mobile apps. Using voluntary standards in premarket submissions can be used more effectively. Even more dramatic, FDA's new Digital Health initiative turns FDA's premarket clearance program on its head.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Excel expert David Ringstrom, CPA, introduces several lookup functions, including VLOOKUP, HLOOKUP, MATCH, and CHOOSE, in this valuable presentation. These powerful Excel functions allow you to rapidly develop accurate spreadsheets and look up information, such as pay rates, item prices, and accounting results, versus manually linking to specific cells. David explains the context of when to use lookup functions, demonstrates troubleshooting techniques, and prepares you to deal with subtle issues that can prevent them from working properly.
Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.
Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
In this webinar, we will explore the hazards related to the laboratory on many fronts. To understand the laboratory work environment as it relates to safety, the employer must consider what the materials the workers are exposed to on a daily basis.
Speaker: Sheldon Primus | View Anytime | Price: $190.00 | View Details
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.
Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.
Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.
Speaker: Vanessa Lopez | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
Speaker: Shep Bentley | View Anytime | Price: $190.00 | View Details
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.
Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This webinar will provide a good understanding on how to effectively conduct and document method validation, method re-validation and periodic review.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision. Decision-makers need at least a cursory knowledge of potential pitfalls to create contingencies, as it is easier and more cost-effective to change things earlier in process than later.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
For manufacturers for drugs, biologics, biosimilars, generics, and medical devices, firms are subject to various statutory and regulatory requirements under FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). To provide safe and effective medical products, it is important for the FDA-regulated industry to accurately understand and apply the applicable regulations and requirements under GLP, GCP and GMP.
Speaker: Dr. David Lim | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Regulation proposals of the European Commission
Speaker: Salma Michor | View Anytime | Price: $190.00 | View Details
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.
Speaker: Salma Michor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe.
Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work. Use OneNote to manage your projects. Use OneNote to manage your meetings. Use OneNote to manage your life.
Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.
Speaker: Jonathan M. Lewis | View Anytime | Price: $190.00 | View Details
Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.
Speaker: Lena Cordie | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Financial institutions and others in the payments ecosystem must comply with regulations related to due diligence of business customers, as well as ongoing monitoring of their portfolios. A strong KYC program also includes an assessment of business customer risk. How can financial institutions and processors effectively determine what the risks are and how to manage them? This session will provide guidance on assessing business customer risk both at onboarding and ongoing, as well as best practices for taking a risk-based approach to Know Your Customer (KYC) and Know Your Customers' Customers (KYCC).
Speaker: Jane Hennessy | View Anytime | Price: $190.00 | View Details
This course covers Root Cause Failure Analysis,Closed Loop Corrective Action, which is used to identity multiple roots to organizational problems and eliminate causes affecting, internal, external customer satisfaction, cost of doing business, quality, schedule, safety and security issues. Emphasis is on evidence gathering for each suspected cause before attempting solutions with The Model for Improvement. Also presented are suggestions for keeping processes safe from competitors and cyber-attacks from insurgents.
Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.
Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
This presentation helps participants understand the FDA's device regulations for Excel workbooks. These workbooks could automate process, influence product decisions, support regulatory submissions, or create electronic records. FDA regulations cover both the use of workbooks and the creation of electronic records; device manufacturers must understand these regulations and their application.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Attribute acceptance sampling is a common tool for medical device manufacturers. Unfortunately, many people don't understand the underlying concepts or the basis for decision making. This presentation explains the underlying ideas of attribute sampling plans and how to use the two most common published plans, Z1.4 and c=0. In addition, the presentation describes the major differences between the approaches. Attribute sampling plans are characterized by the operating characteristic curve (OC curve) which provides the basis for sampling risk. The presentation explains how to read the OC and use it to help select sampling plans.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.
Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are going to be areas inspectors will be focussing on.
Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Speaker: Angela Bazigos | View Anytime | Duration: 2 Hours | Price: $190.00 | View Details
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This webinar will provide a good understanding on how to effectively conduct and document method validation, method re-validation and periodic review.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any other time during the lifecycle of the product, that a product be safe whenever humans are being exposed to it for the first time. In any stage during the lifecycle of the drug product, a product is considered adulterated and therefore, illegal for sale, if it is not manufactured using good manufacturing practices.
Speaker: Stephanie Cooke | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
You will learn the basics of creating and using Excel pivot tables in this valuable webcast presented by Excel expert David Ringstrom, CPA. Pivot tables allow you to create reports from complex data simply by using your mouse. Pivot tables have a few nuances that can trip up the unaware user, so David points out the traps and shares tricks that will help ensure the reports you create are accurate.
Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.
Speaker: Betty Lane | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.
Speaker: Thomas Bento | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
This webinar details the regulation and how it applies to computerized systems.
Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This Webinar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work. Use OneNote to manage your projects. Use OneNote to manage your meetings. Use OneNote to manage your life.
Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe
Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.
Speaker: Roger Cowan | View Anytime | Price: $190.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct.
Speaker: Charles H Pierce | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management.We'll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A project is a temporary endeavor undertaken to create a unique product, service or result. Project management is the application of knowledge, skills, tools and techniques to project activities to meet the project requirements. Companies have come to recognize the importance of project management in helping them achieve their objectives and have added this to their organizational structure. Project management started with the construction industry and has evolved over time.
Speaker: Carol Friedhoff | View Anytime | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
This course will help participants examine issues on the project from multiple viewpoints. While a General Contractor certainly has one perspective on the project, so too do the Owner, Architect/Engineer, Subcontractors, and other Stakeholders. By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals for additional work will be accepted.
Speaker: Heath Suddleson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard.
Speaker: Brian Shoemaker | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Trying to understand the "Agile method" as just another software development lifecycle, with specific rules and a fixed outline, is mistaken, and seriously limits the benefits that Agile can bring. Successful Agile implementations include development, operations and business functions right from the outset. Anything less just creates another process island and cross function friction. All functions must participate actively throughout development, since development is recognized to require learning and adapting (and market needs can change rapidly).
Speaker: Brian Shoemaker | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Device cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA's premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit. Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance. Systems may also be used to monitor and/or control FDA-regulated processes and equipment, handle product labeling, product lot control, clinical trial and trial sample management, and many other processes.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Speaker: Angela Bazigos | View Anytime | Duration: 2 Hours | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Recent events have highlighted sophisticated cybersecurity attacks everywhere including the White House.Corporations have been attacked at an alarming rate. What does this mean for computer systems validation?
Speaker: Valarie King Bailey | View Anytime | Price: $190.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
Change control, is by its nature and scope, is the most significant QMS intersection. Yet there are no specific QMS regulations that clearly define all areas to be considered. Rather, the scope is defined by the products, processes, and related regulations. Document control is an element of change control, as well as one of the feeder systems, and is also an outcome of change control. In process terms, document control can be an input, a process step and an output of the change control process. Document control is a foundational element of the QMS and provides the structure and support for many other elements, including change control and CAPA.
Speaker: Deb Simpson | View Anytime | Price: $190.00 | View Details
This class will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Do you work with "Big Data"? Do you import, manipulate and analyze massive datasets in Excel? If so you'll already be familiar with the limitations of Excel. Power Pivot and Power Query, two free addins for Excel, are designed to get you past these limitations, allowing you to import and work with 1-million-plus-row datasets from virtually any source. If you ever need to create pivot tables from multiple datasets, Power Pivot is your friend. No more vlookup. No more multiple consolidation ranges. If you've been frustrated by other limitations of pivot tables then Power Pivot is for you. Simply put, Power Pivot takes pivot tables and data analysis to the next level. If you're a fan of pivot tables, you'll love Power Pivot.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work. Use OneNote to manage your projects. Use OneNote to manage your meetings. Use OneNote to manage your life.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit-and-loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job. Functions are built-in formulas that have been programmed to perform a specific calculation. They range from the simple such as SUM and AVERAGE (used to calculate the total and average of numbers in a range of cells) to the powerful IF and VLOOKUP. Functions aren't limited to calculating numeric data.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world".
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA, with assistance from the FTC, has become increasingly aware of the large amount of dietary supplements that have come onto the market since the passage of the Dietary Supplement Health and Education Act in 1994. A growing public demand for supplements, along with a relatively relaxed pre-market approval process, has resulted in a flurry of companies creating and marketing their own dietary supplements in the United States. With FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.
Speaker: James E. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Device cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA's premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation.You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management.We'll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.
Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.
Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
This webinar details the regulation and how it applies to computerized systems.
Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate data integrity, security and availability of electronic records but also related to validation of software and computer systems. However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what the FDA is looking for in these inspections.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.
Speaker: Jonathan M. Lewis | View Anytime | Price: $190.00 | View Details
Companies and other entities, such as non-profit organizations and government agencies, are vulnerable to a wide variety of internal and external fraud schemes.A prevalent fraud that occurs is improper payments to vendors, fictitious vendors, and related party vendors.A dishonest employee can easily manipulate vendor and accounts payable records to facilitate fraudulent disbursements. The Association of Certified Fraud Examiners claims that nearly two thirds of an entity's fraud exposure involve fraudulent disbursements.Due to the prevailing hazard surrounding fraudulent disbursements, it is imperative that an organization's accounting department, internal auditors, external auditors, and fraud examiners undertake an ongoing robust, cost effective, review of the internal controls over the cash disbursement process. Preventing fraudulent disbursements is the goal with a secondary objective of early detection.
Speaker: John E. Grimes | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants.
Speaker: Greg Martin | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation. The presentation examines elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485:2016.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met. This session will delve into several key areas for applying Agile in the medical device context, including:
Speaker: Brian Shoemaker | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate data integrity, security and availability of electronic records but also related to validation of software and computer systems. However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what the FDA is looking for in these inspections.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier's acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your expectations. This is a first step in selecting the correct supplier to meet your outsourcing needs.
Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
This webinar details the regulation and how it applies to computerized systems.
Speaker: Edwin Waldbusser | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Excel expert David Ringstrom, CPA, shows you how to implement internal control features within your Excel spreadsheets in this enlightening presentation. David uses a simple invoice form as a teaching aid to present various ways to control users' actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. David demonstrates every technique at least twice first, on a PowerPoint slide with numbered steps, and second, in Excel 2016. He'll draw to your attention any differences in Excel 2013, 2010, or 2007 during the presentation as well as in his detailed handouts. David also provides an Excel workbook that includes most of the examples he uses during the webcast.
Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This Webinar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g for data capture, data evaluation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to control, validate and use Excel® requirements can be met. Attendees of this webinar will get all details on how requirements can be met.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
For any of us who perform attestation functions, peer review is part of our world. The peer review process is a requirement for us to maintain the highest level of compliance with our professional guidance. Spend some time with us learning about the most common mistakes made during compilation and review engagements, because for every mistake (deficiency) noted in a peer review time must be spent in remediation and possibly even new education or even worse penalties.
Speaker: Candace Leuck | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics..
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This training is designed to help process plant management teams work together to prevent and eliminate risk to food safety. The FDA has a legislative mandate to require comprehensive, science-based preventive controls across the nation's food supply.Food facilities are required to implement a written Hazard Analysis and Risk-based Preventive Controls (HARPC) plan. This coms by way of a five step approach
Speaker: Thomas Perkins | View Anytime | Price: $190.00 | View Details
This session will raise awareness of fraud issues in Accounts Payable and examine processes to mitigate the risk associated with Accounts Payable to comply with SOX. It will provide you with the tools you need to establish and maintain strong internal controls that meet Sarbanes-Oxley standards by reducing risk and protecting company assets.
Speaker: Mike Morley | View Anytime | Price: $190.00 | View Details
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management. What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.
Speaker: Charles H. Paul | View Anytime | Price: $190.00 | View Details
We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager. We must become Project Leaders. Much of this transformation comes from the use of our attitude.
Speaker: Heath Suddleson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
To gain insight with regard to future expectations of the FDA with regard to quality metrics. Since the publication of the draft guidance there have been independent studies performed on behalf of the FDA.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S Custom's ACE software program require more information from the foreign source(s).FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise,you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This program is going to be presented to give the attendees a better or broader perspective of how to use this program from a more comprehensive understanding based upon how this system has been proven to be very successful in gaining FDA approval when the field inspectors have come in to do their job to ensure this facility is operating in a way that is very reliable and consistent in dong what is needed to minimize patient risk.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. These include experiments appropriate for screening, optimization, mixtures/formulations, etc. Several important techniques in experimental design (such as replication, blocking, and randomization) are introduced. A Case Study involving optimizing a manufacturing process with multiple responses is presented.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world"
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation.You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management.We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe
Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.
Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.
Speaker: Michael Brodsky | View Anytime | Price: $190.00 | View Details
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.
Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. The deviation process is explored and evaluated and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.
Speaker: John R. Godshalk | View Anytime | Price: $190.00 | View Details
This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.
Speaker: John R. Godshalk | View Anytime | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can we use to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.
Speaker: Dr. Ludwig Huber | View Anytime | Price: $190.00 | View Details
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way?
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect.
Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. In the meantime the USP has published an updated general chapter <1224>.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program. Just in the last three years, FDA issued more than 30 warning letters with Part 11 and data integrity violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control". SPC is a statistical tool that objectively identifies when it is worthwhile to perform a formal investigation of manufacturing variation, in order to identify and reduce its cause.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.
Speaker: Michael Brodsky | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Price: $190.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met. FDA back in June 2016 issued a final rule to allow for the use of standalone symbols on medical device and in vitro diagnostic (IVD) labels in an effort to align with international standards. In addition to allowing the use of standalone symbols, the final rule also permits the use of the symbol statements "Rx only" and "Rx only" for prescription devices. FDA says the finale rule is optional, though the agency thinks that it will be a boon to industry and estimates the reduced workload will result in annual savings of up to $25.5 million.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar provides a brief history of the Bayh-Dole Act, where it is managed within the federal government, the invention reporting requirements of grantees to the federal government, an example of how a university coordinates invention reporting requirements to complete timely reporting requirements of the Act. In addition to those provisions that apply to all organizations, non-profit organizations are subject to three obligations that those that seek intellectual property rights via license contracts need to be aware of.
Speaker: Ronald Kudla | View Anytime | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
To gain insight with regard to future expectations of the FDA with regard to quality metrics. Since the publication of the draft guidance there have been independent studies performed on behalf of the FDA.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
With $49 billion worth of imported foods, the FDA and its regulatory allies oversee more than 420,000 domestic and foreign facilities.
Speaker: John Ryan | View Anytime | Price: $190.00 | View Details
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Many companies have failed to achieve the potential benefits from the application of statistical process control due to widespread misunderstanding and misapplication of the methods. When misapplied, great improvements in quality and productivity are not achieved. The consequences of the improper application of SPC include: devastating inefficiencies, poor purchasing decisions, a false sense of reality, and processes controlling human behavior rather than the humans controlling process behavior.
Speaker: Steven Wachs | View Anytime | Price: $190.00 | View Details
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Speaker: Angela Bazigos | View Anytime | Price: $190.00 | View Details
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last four years FDA has issued more than 30 warning letters with Part 11 deviations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
In the last couple of years FDA has increasingly observed CGMP violations involving data integrity lapses during CGMP inspections. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. For better understanding FDA's data integrity expectations the agency has published a draft guidance answering 18 questions related to data integrity for cGMP compliance.
Speaker: Dr. Ludwig Huber | View Anytime | Price: $190.00 | View Details
This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.
Speaker: John R. Godshalk | View Anytime | Price: $190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
For analysis purposes, the financial statements that typically used are the balance sheet, the income statement and the cash flow statement. The lack of any appreciable standardization of financial reporting terminology complicates the understanding of many financial statement account entries. This circumstance can be confusing for the beginning reader.
Speaker: Greta Hicks | View Anytime | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Price: $190.00 | View Details
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Deficient through wall flashing systems are the predominant cause of water leakage into the through the building enclosure system. The results of such leaks are building enclosure system failures, structural element failures, the growth of mold spores and fungus in building enclosure systems and degraded indoor air quality.
Speaker: Leonard Anastasi | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently. It's all the more important as data collection has become more automated and you're getting swamped with tons of data.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Any company that submits IRS Forms 1099 to the IRS can possibly benefit from using the IRS Taxpayer Identification Number (TIN) Matching program. The program is a free service included in IRS e-services. Any authorized person can access e-services and submit payees for the matching process. The IRS will not tell you the correct TIN but they will let you know that the TIN and Name combination you submitted is incorrect. You can then go back to the payee for a corrected form W-9, which is a request for a Taxpayer Identification Number. A correct W-9 is the key to a correct Form 1099.
Speaker: Greta Hicks | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
PivotTable capabilities are enormous; among its many tools and features
Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
This webinar provides a brief history of the Bayh-Dole Act, where it is managed within the federal government, the invention reporting requirements of grantees to the federal government, an example of how a university coordinates invention reporting requirements to complete timely reporting requirements of the Act. In addition to those provisions that apply to all organizations, non-profit organizations are subject to three obligations that those that seek intellectual property rights via license contracts need to be aware of.
Speaker: Ronald Kudla | View Anytime | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl Leinsing | View Anytime | Price: $190.00 | View Details
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
Speaker: Karl Leinsing | View Anytime | Price: $190.00 | View Details
This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.
Speaker: Anne Tomalin | View Anytime | Price: $190.00 | View Details
This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Reliability Plotting is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for data that is problematic in one or more of the following ways: non-normal (e.g., a Fatigue-Life distribution), a mixture of distributions (e.g., the distribution looks bi-modal when arranged into a histogram), low precision (e.g., a large number of identical readings in a small sample size), and/or incomplete (e.g., when a study is terminated before all on-test devices can be measured, due either to measurement equipment limitations or due to time limitations). Reliability plotting can easily handle all such situations.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
The Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025:2005 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.
Speaker: Michael Brodsky | View Anytime | Price: $190.00 | View Details
Becoming accredited is a verification of the laboratory's capability of producing reliable results in accordance with the requirements of ISO/IEC 17025. Accreditation is not a guarantee of analytical competency. Getting accredited is just the beginning. The journey begins with defining the laboratory's operating principals and policies.
Speaker: Michael Brodsky | View Anytime | Price: $190.00 | View Details
This is part 1 of a three part required training resulting from the finalization of new US FDA food transportation laws.
Speaker: John Ryan | View Anytime | Price: $190.00 | View Details
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.
Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.
Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.
Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.
Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
DTC involves various platforms to convey a message, social media, broadcast media, print media and the internet. Each of these platforms have special criteria to define what you can and cannot do. FDA treats those criteria in a stringent manner. FDA "trolls" these platforms to catch firms running fowl of the FDA's guidance on DTC. If they catch you, they can.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
Many companies have failed to achieve the potential benefits from the application of statistical process control due to widespread misunderstanding and misapplication of the methods. When misapplied, great improvements in quality and productivity are not achieved. The consequences of the improper application of SPC include: devastating inefficiencies, poor purchasing decisions, a false sense of reality, and processes controlling human behavior rather than the humans controlling process behavior.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them.
Speaker: John R. Godshalk | View Anytime | Price: $190.00 | View Details
This webinar explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.
Speaker: John R. Godshalk | View Anytime | Price: $190.00 | View Details
This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.
Speaker: John R. Godshalk | View Anytime | Price: $190.00 | View Details
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Price: $190.00 | View Details
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 24 months FDA issued more than 30 warning letters with citations Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
Since the year 2000 there has been an increasing trend of registered clinical studies from approximately 4,000 in 2000 to 160,000 in 2014. In 2014 Forbes Magazine reported that the FDA had approved 44 drugs the highest in 18 years.
Speaker: Harold Thibodeaux | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Companies need to stay internationally competitive and this webinar on export certificates provides a key link for entry to markets around the globe. This webinar will explore the export approval and certification process in the U.S. It will include guidance on preparing applications and obtaining FDA's certification that specific products identified for export meet U.S. regulatory requirements. All of this will be valuable in obtaining broader access to global markets.
Speaker: Larry Spears | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Studies demonstrate that just 5 contract clauses can raise prices up to 20% and lead project failure and litigation claims. What are examples of poorly drafted killer clauses and how can you avoid them to get better project results.
Speaker: Brian Perlberg | View Anytime | Price: $190.00 | View Details
The FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.
Speaker: Casper Uldriks | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
GMP Fundamentals of Pharmaceutical HVAC :System This part will discuss the benefits of HVAC system in pharmaceutical industries as well as discussing the contamination sources that must be prevented where this section will give information about how bad HVAC can be risky on both process or humane comfort as well
Speaker: Majdi Ayoub | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
The last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA come under increasing negative public scrutiny.
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The FDA recommended course includes actual data, costs and examples from transportation tracked and measured operations, important definitions and reviews of federal and international requirements, established standards for management, HARPC, sanitation, temperature monitoring and traceability and training, types of adulterants, preventive practices, vehicle qualification, pre-shipment inspection, contamination flows, unseen bacteria, container temperature losses, obvious violations, the most advanced temperature monitoring, pallet types, carrier responsibilities, sanitation testing, and includes specific recommendations for carriers as well as shippers and receivers who receive carrier services.
Speaker: John Ryan | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.
Speaker: Anne Tomalin | View Anytime | Price: $190.00 | View Details
This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Speaker: Anne Tomalin | View Anytime | Price: $190.00 | View Details
This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Speaker: Anne Tomalin | View Anytime | Price: $190.00 | View Details
Payroll Updates will give you an understanding of the latest regulation changes that impact your company including but not limited to; Changes in the duties test, updated "Primary Duties" and "Permit to Suffer" changes, how to classify "working time or worked time", exempt and non-exempt, proposed rules changes in classifications for 2016 "new rules", how to calculate overtime, understanding taxable gifts, bonus and awards (parking, achievement awards, length of service awards, athletic facilities, deminmus benefits, 2016 mileage rates, common pitfalls of Wage and Hour laws that can be costly, when you can give 'Comp Time" instead of overtime, Misclassification of Employees as Independent Contractors, understand common Law Rules-Facts that provides evidence of the degree of control and independence plus Best Practices in Payroll
Speaker: David Sanders | View Anytime | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.
Speaker: Karen Greene | View Anytime | Price: $190.00 | View Details
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Speaker: Angela Bazigos | View Anytime | Duration: 2 Hours | Price: $190.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Speaker: Angela Bazigos | View Anytime | Price: $190.00 | View Details
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Price: $190.00 | View Details
This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control". SPC is a statistical tool that objectively identifies when it is worthwhile to perform a formal investigation of manufacturing variation, in order to identify and reduce its cause.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Reliability Plotting is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for data that is problematic in one or more of the following ways: non-normal (e.g., a Fatigue-Life distribution), a mixture of distributions (e.g., the distribution looks bi-modal when arranged into a histogram), low precision (e.g., a large number of identical readings in a small sample size), and/or incomplete (e.g., when a study is terminated before all on-test devices can be measured, due either to measurement equipment limitations or due to time limitations). Reliability plotting can easily handle all such situations.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Price: $190.00 | View Details
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
In the calendar year 2015, the pharmaceutical industry witnessed the largest number of Food and Drug Administration (FDA) prescription drug approvals in the past decade. The FDA's Center for Drug Evaluation and Research played a valuable and key role in bringing these drugs to market.
Speaker: Harold Thibodeaux | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
For medical professionals involved with clinical development of drugs and medical devices, they are well educated that the Food and Drug Administration (FDA) is the regulating agency that provides the regulatory requirements necessary for final approval.
Speaker: Harold Thibodeaux | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring (EM) Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring (Pre-qualification through post-qualification EM) and what each type stands for. List the basic content of a well-designed, effective and compliant EM Program. Explain the relationship between an EM Excursion Program and CAPA
Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.
Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.
Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork.
Speaker: Karl Leinsing | View Anytime | Price: $190.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
The FDA, with assistance from the FTC, has become increasingly aware of the large amount of dietary supplements that have come onto the market since the passage of the Dietary Supplement Health and Education Act in 1994. A growing public demand for supplements, along with a relatively relaxed pre-market approval process, has resulted in a flurry of companies creating and marketing their own dietary supplements in the United States. With FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.
Speaker: James E. Russell | View Anytime | Price: $190.00 | View Details
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
It is just a fact of life that someone on your team, whether you selected them or whether they were assigned to you will be a non-performer. This may be because they are simply not performing to the level desired or it may be an issue of time management, or even an issue of motivation.
Speaker: Heath Suddleson | View Anytime | Price: $190.00 | View Details
We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager. We must become Project Leaders. Much of this transformation comes from the use of our attitude.
Speaker: Heath Suddleson | View Anytime | Price: $190.00 | View Details
This course will help participants examine issues on the project from multiple viewpoints. While a General Contractor certainly has one perspective on the project, so too do the Owner, Architect/Engineer, Subcontractors, and other Stakeholders. By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals for additional work will be accepted.
Speaker: Heath Suddleson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
To develop appropriate Quality Control Practices and acceptability criteria to evaluate the performance of analytical materials for laboratory use
Speaker: Michael Brodsky | View Anytime | Price: $190.00 | View Details
Intentional contamination or adulteration of food is a reality. We will review some examples of the dire consequences of adulteration ostensibly for economic gain This webinar will also discuss the potential threats of using food as biological weapon and the actions food companies can take to mitigate and minimize the risks of food bioterrorism.
Speaker: Michael Brodsky | View Anytime | Price: $190.00 | View Details
Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.
Speaker: Anne Tomalin | View Anytime | Price: $190.00 | View Details
This topic will cover the regulatory submission required in Canada (Clinical Trial Application) and comparison to Clinical Trial Applications in Europe and Investigational New Drug Submissions in the EU. Also covered will be the submission of documentation to Institutional Review Boards, the membership of these boards, and common findings of deficiencies for such Boards. Again, a comparison will be made to the US and EU.
Speaker: Anne Tomalin | View Anytime | Price: $190.00 | View Details
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device
Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
A project is a temporary endeavor undertaken to create a unique product, service or result. Project management is the application of knowledge, skills, tools and techniques to project activities to meet the project requirements. Companies have come to recognize the importance of project management in helping them achieve their objectives and have added this to their organizational structure. Project management started with the construction industry and has evolved over time.
Speaker: Carol Friedhoff | View Anytime | Price: $190.00 | View Details
Look-up formulas such as VLOOKUP allow you to return data from other locations in your spreadsheets without linking to individual worksheet cells. However, VLOOKUP can't always return the data that you need. In this session Excel expert David Ringstrom, CPA explores the nuances and limitations of VLOOKUP, helps you expand your use of this function, and then leaves you with a handful of alternatives.
Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.
Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
You'll not only learn how to control a user's actions, but you'll also learn how to make your spreadsheets as future-proof as possible. You'll also learn techniques that can significantly save you time when making a spreadsheet as "user-proof" as possible.
Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
You've likely experienced the "blur" that sets in when you're working in a large spreadsheet. Or the frustration in tasks that consume far more time in Excel than you feel they should.
Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
This webinar will cover the major issues facing the multifamily housing market with an emphasis on the outlook for new construction. Coverage will include discussion regarding the preference for owning vs. renting, availability of credit for residential purchases by the consumer and for developers, the direction and speed of change in interest rates, the outlook for multifamily condominium units, and availability of labor for construction.
Speaker: Bernard Markstein | View Anytime | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Based on the FDA FSMA rules for preventive controls and their emphasis on planning for and implementing preventive systems, the final rules require that food supply chain members understand new supply-chain-applied control requirements.
Speaker: John Ryan | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes. For food shippers, carriers and receivers, standardization or upgrade to current practices is critical. For buyers, knowing how to establish standards for your food transporters sets the stage for required supply chain controls.
Speaker: John Ryan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
This 60 minute webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. The session will also cover associated information like identification, classification and protocols.
Speaker: John Ryan | View Anytime | Price: $190.00 | View Details
Real world examples of what to expect, and what to prepare for whenever possible. Not every organization is ready to avoid inspections or fines if they do not have senior staff in place, and/or if they have not been audited in the past.
Speaker: Jason Teliszczak | View Anytime | Price: $190.00 | View Details
The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Normality Tests and normality transformations are a combination of graphical and numerical methods that have been in use for many decades. These methods are essential to apply whenever a statistical test or method is used whose fundamental assumption is that the inputted data is normally distributed.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.).
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Price: $190.00 | View Details
Pre-Control is easier than SPC! With no control limits to calculate and go/no go colored zones, this control tool can rapidly help to reduce process variation. Participants will observe a modeled session that both develops and runs a Pre-Control chart.
Speaker: Jd Marhevko | View Anytime | Price: $190.00 | View Details
A review of basic AAA analysis. Will cover the 3 basic types of agreements: Agreement with oneself, Agreement to a peer, Agreement to the standard. Both the "Statistical AAA" and the Kappa value will be reviewed. Confidence levels for the result bands will also be reviewed. Incorporation of AAA into the Control Plan and frequency of "calibration" will be reviewed.
Speaker: Jd Marhevko | View Anytime | Price: $190.00 | View Details
This session shows practitioners how to develop and create a Paynter Chart for predictive warranty management. Attendees will see how to actively utilize representative return data, observe the construction of a sample Paynter and then observe the results of the predictive analysis.
Speaker: Jd Marhevko | View Anytime | Price: $190.00 | View Details
Come celebrate the union of the PFMEA and the CP! See how the Dynamic Control Plan (DCP) combines both tools into ONE enabling the savings of hundreds of hours of Engineering time, reducing the risk of documentation errors, and, actually improving QMS effectiveness while reducing repetitious work. This session will show you how you can benefit from the DCP!
Speaker: Jd Marhevko | View Anytime | Price: $190.00 | View Details
Effective sanitation in the food industry involves the maintenance of clean conditions in the entire food operation. This status is attained through the destruction of residual microorganisms after cleaning of production, storage and service areas of food establishments.
Speaker: Norman G. Marriott | View Anytime | Price: $190.00 | View Details
The European Medicines Agency plays an important role in the development of medicines for children. In the past, many medicines authorized in Europe were not studied adequately or authorized in children. This caused difficulties for prescribers and pharmacists treating children, as well as for their patients and careers.
Speaker: Adriaan Fruijtier | View Anytime | Price: $190.00 | View Details
Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following advice from the Regulatory Authorities increases the probability of a positive outcome.
Speaker: Adriaan Fruijtier | View Anytime | Price: $190.00 | View Details
The European Medicines Agency plays a central role in the development and authorization of medicines for rare diseases. These medicines are termed ‘orphan medicines’ in the medical world.
Speaker: Adriaan Fruijtier | View Anytime | Price: $190.00 | View Details
This webinar will deal with the many different post-approval changes and describe which procedure has to be followed. Variations are either:
Speaker: Adriaan Fruijtier | View Anytime | Price: $190.00 | View Details
This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on the Autism Spectrum.
Speaker: Jd Marhevko | View Anytime | Price: $190.00 | View Details
Developing an effective HACCP plan requires a clear understanding of the principles and specific steps involved in a HACCP study. This webinar will teach you through step by step process detailing how the user can build a plan capable of identifying and controlling food safety hazards relevant to your products and processes.
Speaker: Rotimi Toki | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Unlike packaged foods that are labelled with nutrition information, foods in restaurants, for the most part, do not have nutrition information that is readily available when ordered. Hence, the need for FDA nutrition - disclosure rules for restaurants to enable consumers make healthier food choices. The compliance date for the new rule is December 1, 2016. This 90-minute webinar will simplify what you need to do to overcome the complex process involves in calculating calories in restaurant meals.
Speaker: Rotimi Toki | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.
Speaker: Karen Greene | View Anytime | Price: $190.00 | View Details
Individuals responsible for medical packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end-user without incurring defect or risk to patient safety.
Speaker: Karen Greene | View Anytime | Price: $190.00 | View Details
Since the year 2000 there has been an increasing trend of registered clinical studies from approximately 4,000 in 2000 to 160,000 in 2014. In 2014 Forbes Magazine reported that the FDA had approved 44 drugs the highest in 18 years.
Speaker: Harold Thibodeaux | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
It is difficult on occasion for EHS practitioners to stay highly motivated because of the "second guessing" and attitude from some of the people we support (our customers) and the people who manage operations (our clients). This presentation is designed to maintain the high level of motivation EHS practitioners need in order to stay effective.
Speaker: James Thatcher | View Anytime | Price: $190.00 | View Details
The worst thing end-user organizations can do is to have an uninformed reaction to surcharging. It's important to first look at the big picture as end-users should also educate suppliers about the economics of card acceptance, pointing out the savings possible and other benefits.
Speaker: Ray Graber | View Anytime | Price: $190.00 | View Details
The yearly payment volumes - B2B only - of processors such as CHIPS, Fedwire, SWIFT, and ACH are growing steadily, while checks are declining at a small single-digit rate.
Speaker: Ray Graber | View Anytime | Price: $190.00 | View Details
If you are looking for ways to improve your Corporate Expense Account Oversight and Reporting, you will find best-of-breed practices and suggestions at a basic level. Finance and Operational staff will find this presentation interesting and informative. This webinar will provide you with some of the best practices in corporate expense account review used today.
Speaker: Mike Morley | View Anytime | Price: $190.00 | View Details
This session will raise awareness of fraud issues in Accounts Payable and examine processes to mitigate the risk associated with Accounts Payable to comply with SOX. It will provide you with the tools you need to establish and maintain strong internal controls that meet Sarbanes-Oxley standards by reducing risk and protecting company assets.
Speaker: Mike Morley | View Anytime | Price: $190.00 | View Details
Attend this presentation and find out what the SEC is watching closely for now and into the future. Like it or not, the SEC is still fining companies and filing criminal charges against company executives. Don’t be one of them.
Speaker: Mike Morley | View Anytime | Price: $190.00 | View Details
As a finance or accounting professional, you should be familiar with exactly what these IFRS standards for Extractive Industries consist of, and what they mean for companies in the oil, gas and mining industries. This webinar will help you become acquainted with the latest information regarding IFRS for companies in the resource sector.
Speaker: Mike Morley | View Anytime | Price: $190.00 | View Details
Business Administration is often very generalized and even more often overlooked by project managers. This course is targeted to teach you the strategic and business administration concepts that are specific to project management.
Speaker: Heath Suddleson | View Anytime | Price: $190.00 | View Details
It is just a fact of life that someone on your team, whether you selected them or whether they were assigned to you will be a non-performer. This may be because they are simply not performing to the level desired or it may be an issue of time management, or even an issue of motivation.
Speaker: Heath Suddleson | View Anytime | Price: $190.00 | View Details
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Susan Brink | View Anytime | Price: $190.00 | View Details
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.
Speaker: Betty Lane | View Anytime | Price: $190.00 | View Details
In financial institution, operational risk has been considered as minor compared to credit risk and market risk. Moreover, Operational Risk is too difficult to grasp for bankers. Therefore operational risk management is often considered as a regulatory constraint or as an imprecise practice rather than a science, and it is often hijacked by political necessities, or can turn into insignificant exercises aimed at predicting small losses or improving efficiency without consideration for high-impact risks.
Speaker: Fred Vacelet | View Anytime | Price: $190.00 | View Details
With $49 billion worth of imported foods, the FDA and its regulatory allies oversee more than 420,000 domestic and foreign facilities.
Speaker: John Ryan | View Anytime | Price: $190.00 | View Details
This webinar is designed to help you understand how the new rules for the sanitary transportation of human and animal foods will impact your logistics operations and to provide you with some of the tools needed to meet new regulations and customer demands.
Speaker: John Ryan | View Anytime | Price: $190.00 | View Details
This webinar provides a brief history of the Bayh-Dole Act, where it is managed within the federal government, the invention reporting requirements of grantees to the federal government, an example of how a university coordinates invention reporting requirements to complete timely reporting requirements of the Act. In addition to those provisions that apply to all organizations, non-profit organizations are subject to three obligations that those that seek intellectual property rights via license contracts need to be aware of.
Speaker: Ronald Kudla | View Anytime | Price: $190.00 | View Details
The webinar covers factors considered by FDA before, during and after an inspection that can be used to predict your inspectional vulnerability. Once you know some key points, you will see that FDA's approach to inspections follows well-established procedures and risk criteria that enables FDA to characterize your firm's compliance. Usually the only way FDA will let you know about your profile is when an official action is indicated. That is not a good thing. Otherwise, you hear very little and even then, you may wait a long time. The cloud of doubt can plague a firm for months.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Social media has become a primary vehicle for reaching buyers, both professional healthcare providers and consumers. The consumers can post whatever they wish, whether it is true, false, an opinion or simply as a joke.
Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
This course will describe the basis for the performance and tools and techniques for performing internal audits in support of the development and manufacture of a pharmaceutical drug product.
Speaker: Joseph Habarta | View Anytime | Price: $190.00 | View Details
How many times does a team push to get projects done to meet the bottom line? The budget and schedule are always priorities and communication falls low on the list. Everybody is concerned how to do the project, not about the project's outcome.
Speaker: Cathy Dolan-Schweitzer | View Anytime | Price: $190.00 | View Details
Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.
Speaker: Jerry Dalfors | View Anytime | Price: $190.00 | View Details
Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.
Speaker: Michael Brodsky | View Anytime | Price: $190.00 | View Details
Attacker's attack 24x7 and Computer Security Incident Response for a company, government agency or organization must also be ready 24X7. Both reporting incidents and disseminating incident-related information correctly is a must.
Speaker: Ms. Michael Redmond | View Anytime | Price: $190.00 | View Details
An organization's security policy and controls must be adaptable to emerging threats in today's world. The assessment of security threats is ongoing, and must be mapped against the adequacy and existence of security controls. Security controls and countermeasures that are currently in in place may not commensurate with potential risks. The effort is never ending, but knowing how to start is the key.
Speaker: Ms. Michael Redmond | View Anytime | Price: $190.00 | View Details
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
FDA's bioresearch monitoring program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas.
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
The first version of USP <1058> has been released in 2008. Since then it has evolved as the global standard for analytical instrument qualification, despite of some deficiencies of the first version.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Documentation is essential for good science. This is especially true in life sciences where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
Speaker: Alla Teresh | View Anytime | Price: $190.00 | View Details
The art and science of pediatric drug development has evolved rapidly in pharmaceutical companies over the last 10 - 14 years because of the encouragement of regulatory agencies in Europe and United States.
Speaker: Robert Kunka | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This session demonstrates how to develop, manage, and implement an effective quality Lean Management System (QLMS) steering committee. Attendees will observe the development of the key components of a steering committee. Several successful examples across various business types will be shared. Attendees will walk away with a model that they can apply to their own organizations.
Speaker: Jd Marhevko | View Anytime | Price: $152.00 | View Details
On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").
Speaker: Adriaan Fruijtier | View Anytime | Price: $146.00 | View Details
"The key to creating and sustaining the kind of successful twenty-first-century organization is leadership - not only at the top of the hierarchy, with a capital L, but also in a more modest sense (l) throughout the enterprise," declares Harvard professor John Kotter. To compete in today's rapidly changing and hyper-competitive marketplace, Kotter adds, "The twenty-first-century employee will need to know more about both leadership and management than did his or her twentieth-century counterpart."
Speaker: Ted Garrison | View Anytime | Duration: 90 Minutes | Price: $144.00 | View Details
The 'why' and 'what' and the events / background that have impacted validation over the last 25 years will be presented.
Speaker: Sam DeMarco | View Anytime | Price: $190.00 | View Details
An FDA investigation can lead to observations requiring remediation, disruption of your business, loss of revenue and enforcement actions up to and including having your plant shutdown. Come learn from someone who's "been there and done that" having gone through an intense FDA investigation with a global manufacturer of durable medical equipment that resulted in the imposition of a Consent Decree and plant shutdown. Take-aways will include practical tips on how to interact with the FDA and create sustainable corrective actions.
Speaker: Drew R Barnholtz | View Anytime | Price: $190.00 | View Details
We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager. We must become Project Leaders. Much of this transformation comes from the use of our attitude.
Speaker: Heath Suddleson | View Anytime | Duration: 90 Minutes | Price: $147.00 | View Details
This course will help participants examine issues on the project from multiple viewpoints. While a General Contractor certainly has one perspective on the project, so too do the Owner, Architect/Engineer, Subcontractors, and other Stakeholders. By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals for additional work will be accepted.
Speaker: Heath Suddleson | View Anytime | Duration: 90 Minutes | Price: $146.00 | View Details
Unlike packaged foods that are labelled with nutrition information, foods in restaurants, for the most part, do not have nutrition information that is readily available when ordered. Hence, the need for FDA nutrition - disclosure rules for restaurants to enable consumers make healthier food choices.
Speaker: Rotimi Toki | View Anytime | Price: $190.00 | View Details
The most important and egregiously written construction contract clauses have been shown to cost a 20% premium on prices and lead to fail projects and litigation. What are examples of poorly drafted killer clauses and how can you avoid them to get better project results.
Speaker: Brian Perlberg | View Anytime | Price: $148.00 | View Details
This webinar will focus on the major fraud and abuse laws, including the Stark Law, the Anti-Kickback Statute, and the False Claims Act. Mr. Wolfe will discuss best practices to minimize liability exposure and penalties, including conducting compliance audits, instituting policies, and establishing ongoing monitoring and reviews. An understanding of the fraud and abuse laws and these best practices will be critical as providers navigate their organizations through this perfect storm.
Speaker: Joseph Wolfe | View Anytime | View Details
This webinar will investigate Stark compliance and valuation implications unique to the group practice and direct employment models and will discuss recent legal developments that further illustrate these concepts.
Speaker: Joseph Wolfe | View Anytime | View Details
This webinar will focus on the major fraud and abuse laws, including the Stark Law, the Anti-Kickback Statute, and the False Claims Act. In this webinar Mr. Wolfe will provide an overview of the health care regulatory issues related to implementing value-based physician compensation models.
Speaker: Joseph Wolfe | View Anytime | View Details
Most large losses have been due, at least partly, to the occurrence of operational risks. Whilst financial institutions like to show that they know about this type of risks, the profession has been slow to learn from other older industries for which risk management is a critical factor.
Speaker: Fred Vacelet | View Anytime | Duration: 90 Minutes | Price: $143.00 | View Details
Internal auditors do not consistently apply basic project management skills throughout the audit process. Auditors tend to "know" how to audit thus believe regimented project management is not necessary.
Speaker: Danny M. Goldberg | View Anytime | Duration: 90 Minutes | Price: $144.00 | View Details
The purpose of this leadership webinar is to take the practice of ethics beyond theory and merge it with accountability. A leader always has a huge influence on whether or not employees behave in an accountable and ethical manner.
Speaker: Ron Rael | View Anytime | Duration: 90 Minutes | Price: $132.00 | View Details
What is a risky decision? How do you size up a risk's impact? How do you hold reckless risk-takers accountable?
Speaker: Ron Rael | View Anytime | Duration: 90 Minutes | Price: $128.00 | View Details
Most ethics presentations and training programs focus on compliance and legal issues-as if ethical choices are either legal or not. The reality is, ethical choices have far more impact on a company long before the issue of "legal or illegal" comes into play. While your Ethics Code of Conduct might meet all the standards required, the missing piece for most companies is the ability to help management and employees understand the human dynamic associated with conduct management.
Speaker: Chuck Gallagher | View Anytime | Duration: 90 Minutes | Price: $120.00 | View Details
With the proliferation of the use of air barriers in building enclosure systems the potential for problems exists in the industry. This workshop will review the proper planning, product selection, specifications, details and field quality assurance needed for a successful air barrier installation.
Speaker: Leonard Anastasi | View Anytime | Price: $154.00 | View Details
As follow up to the Four Barriers For Four Wetting Potentials presentation, this presentation focuses on design considerations for air barrier systems. Products and systems are reviewed and critiqued. Ancillary building enclosure system components are discussed. Problematic areas of the building enclosure system are brought to attention.
Speaker: Leonard Anastasi | View Anytime | Price: $148.00 | View Details
Make sure our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP) as well as vendors supplying product specific raw materials unique to this product.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: $158.00 | View Details
Join Brad as he discusses how lean principles such as flow of inventory, disciplined processes, empowered people, problem solving and visual management will reduce waste and drive measurable results in cost, quality, safety, productivity, utilization, and inventory reduction.
Speaker: Brad Bossence | View Anytime | Price: $153.00 | View Details
As long as increase in the regulatory requirements and market needs which causes conflicts between inspectional parties and manufacturers along with limited resources for each party, there must be a harmonized baseline between two parties that both must agree on. Upon achieving this harmonization, this will minimize the efforts that will in turn increase the quality of the product.
Speaker: Majdi Ayoub | View Anytime | Duration: 90 Minutes | Price: $151.00 | View Details
This webinar provides a brief history of the Bayh-Dole Act, where it is managed within the federal government, the invention reporting requirements of grantees to the federal government, an example of how a university coordinates invention reporting requirements to complete timely reporting requirements of the Act.
Speaker: Ronald Kudla | View Anytime | Duration: 90 Minutes | Price: $143.00 | View Details
Are you responsible for payroll or employer tax withholding compliance? Or maybe you were recently hired or promoted into the payroll department. During your indoctrination you are surprised at all the interesting things to do and how important this role is to the success of the company.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.
Speaker: Robert Kunka | View Anytime | Duration: 90 Minutes | Price: $127.00 | View Details
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $145.00 | View Details
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $157.00 | View Details
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $153.00 | View Details
Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.
Speaker: Karen Greene | View Anytime | Price: $148.00 | View Details
You'll not only learn how to control a user's actions, but you'll also learn how to make your spreadsheets as future-proof as possible. You'll also learn techniques that can significantly save you time when making a spreadsheet as "user-proof" as possible.
Speaker: David Ringstrom | View Anytime | Price: $153.00 | View Details
You've likely experienced the "blur" that sets in when you're working in a large spreadsheet. Or the frustration in tasks that consume far more time in Excel than you feel they should.
Speaker: David Ringstrom | View Anytime | Price: $152.00 | View Details
Why are the top things you need to need to consider changing to standard construction contracts, as well as filling out the blanks correctly! Consequential Damages? Payment Terms? Project Financial Information, Termination? Dispute Mitigation Procedures? The answer is you need to be aware of all the top terms to stay on top of your game.
Speaker: Brian Perlberg | View Anytime | Price: $146.00 | View Details
A project is a temporary endeavor undertaken to create a unique product, service or result. Project management is the application of knowledge, skills, tools and techniques to project activities to meet the project requirements. Companies have come to recognize the importance of project management in helping them achieve their objectives and have added this to their organizational structure. Project management started with the construction industry and has evolved over time.
Speaker: Carol Friedhoff | View Anytime | Price: $132.00 | View Details
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.
Speaker: Jonathan M. Lewis | View Anytime | Price: $161.00 | View Details
Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.
Speaker: Jonathan M. Lewis | View Anytime | Price: $158.00 | View Details
In one hour, you can master the art of reading and understanding your financial statements. No formal accounting training is necessary. No homework will be assigned. And, the information is valuable immediately and forever for your current business.
Speaker: Richard Melancon | View Anytime | Price: $138.00 | View Details
Moms control 85% of all household spending. Moms hold the biggest influence on what brands their children will buy. Moms have strong online networks and rely on referrals from other moms. Make a mom happy and you’ve got the whole family plus all of her friends as new members.
Speaker: Shari Storm | View Anytime | Price: $132.00 | View Details
Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. Proper Environmental Cleaning is just as important as the cleaning of the "inside" of food processing equipment. The exterior of equipment, floors, walls, ceilings, doorways and drains can be a major source of microbial contamination if not properly controlled.
Speaker: Donald Jones | View Anytime | Price: $127.00 | View Details
The Failure Mode Effects Analysis breaks down the analysis of complex software functions into manageable subsystems and modules. It can have a number of variations which address different aspects of the device.
Speaker: Dev Raheja | View Anytime | Price: $146.00 | View Details
Research resources are too scarce to be squandered going down blind alleys and coming up empty handed at project end. We can no longer afford to play hunches or to rely on so called experts, whose opinions all differ, to guide research. Nor can we rely on the gross inefficiencies of old-fashioned one-factor-at-a-time experimentation to guide decisions. Instead, R&D must proceed systematically and with a goal of using unbiased data to guide decisions, following an overall strategy guided by statistical thinking and the scientific method.
Speaker: Lynne Hare | View Anytime | Duration: 90 Minutes | Price: $126.00 | View Details
With $49 billion worth of imported foods, the FDA and its regulatory allies oversee more than 420,000 domestic and foreign facilities.
Speaker: John Ryan | View Anytime | Duration: 75 Minutes | Price: $126.00 | View Details
This 60 minute webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. The session will also cover associated information like identification, classification and protocols.
Speaker: John Ryan | View Anytime | Duration: 75 Minutes | Price: $128.00 | View Details
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Susan Brink | View Anytime | Price: $144.00 | View Details
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based.
Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.
Speaker: John E Lincoln | View Anytime | Price: $137.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $141.00 | View Details
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $162.00 | View Details
The United Nations Convention Against Corruption was formed as a committee in 2003 to help combat what was being seen as an epidemic against free trade. Organizations working in the international arena now face greater regulatory challenges to continue practicing, to educate their employees, and to monitor for violations. The legal loophole is spreading and the FCPA has recently held financial institutions liable for not reporting clients who fail to comply with FCPA requirements.
Speaker: Denise Cicchella | View Anytime | Price: $141.00 | View Details
In 2004, the Committee of Sponsoring Organizations of the Tread way Commission (COSO), issued a principle-based guidance on designing and implementing an effective enterprise-wide approach to risk management. This guidance defines essential components - such as risk appetite, risk tolerance and portfolio view, provides guidance using common principles, and provides counseling and strategy for an effective program.
Speaker: Denise Cicchella | View Anytime | Price: $137.00 | View Details
Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing.
Speaker: Larry Spears | View Anytime | Duration: 90 Minutes | Price: $148.00 | View Details
Whether you are new to risk management or a seasoned veteran tuning up your risk program is constantly required. This program, "What good risk management is so elusive" is designed to make the process of risk management simple.
Speaker: James Bone | View Anytime | Price: $152.00 | View Details
The core components of AML are simple however the execution of effective Know Your Customer compliance is very complex. If you would like to gain stronger assurance about the effectiveness of your AML program using data analytics this webinar is designed to help you develop a simple analytical model for improving the assurance of your AML program.
Speaker: James Bone | View Anytime | Price: $148.00 | View Details
This webinar will focus on identifying the critical components that a Project or Program Manager must be aware of and how to develop plans for effectively and efficiently dealing with them.
Speaker: Drex Rutledge | View Anytime | Price: $124.00 | View Details
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $167.00 | View Details
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $163.00 | View Details
Stress-testing requires lateral knowledge and skills to be thoroughly pursued and constantly updated. It is no longer enough to neglect low-likelihood risks, even when there few or no past occurrences of these risks, and if the perspective looks far away.
Speaker: Fred Vacelet | View Anytime | Duration: 90 Minutes | Price: $140.00 | View Details
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $157.00 | View Details
We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork.
Speaker: Karl Leinsing | View Anytime | Price: $147.00 | View Details
Today's educated professionals in the earth sciences function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. With environmental issues and the use of our natural resources a pressing concern, how does one understand and utilize geology? How is geology different from civil engineering?
Speaker: Mark Brengelman | View Anytime | Price: $131.00 | View Details
Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing. The stakes are made even higher as device regulatory authorities around the globe are harmonizing their regulatory standards and requirements while increasing their collaborative efforts to ensure product safety.
Speaker: Larry Spears | View Anytime | Price: $147.00 | View Details
Bioresearch monitoring program or BIMO is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research
Speaker: Omid Khodai | View Anytime | Duration: 90 Minutes | Price: $148.00 | View Details
Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.
Speaker: Omid Khodai | View Anytime | Duration: 90 Minutes | Price: $146.00 | View Details
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: $137.00 | View Details
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Speaker: Thomas E. Colonna | View Anytime | Price: $138.00 | View Details
In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.
Speaker: Thomas E. Colonna | View Anytime | Price: $134.00 | View Details
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will discuss legal developments in the area of taxation of internet sales
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $145.00 | View Details
Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $146.00 | View Details
We will begin with the methods of identifying workers who may be non-resident aliens and proceed to the forms and methods of collecting the necessary information to determine whether back-up withholding is required. Next we will examine the rules and forms for proper depositing of back-up withholding taxes and the required reporting to the worker as well as to the IRS. Please note, beginning in 2014 the number and complexity of the forms have both increased due to the implementation of FATCA, the Foreign Accounts Tax Compliance Act.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $142.00 | View Details
Companies need to stay internationally competitive and this webinar on export certificates provides a key link for entry to markets around the globe. This webinar will explore the export approval and certification process in the U.S. It will include guidance on preparing applications and obtaining FDA's certification that specific products identified for export meet U.S. regulatory requirements. All of this will be valuable in obtaining broader access to global markets.
Speaker: Larry Spears | View Anytime | Duration: 90 Minutes | Price: $146.00 | View Details
Documentation is essential for good science. This is especially true in life sciences where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
Speaker: Alla Teresh | View Anytime | Price: $144.00 | View Details
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.
Speaker: Betty Lane | View Anytime | Price: $147.00 | View Details
This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity.
Speaker: Betty Lane | View Anytime | Price: $148.00 | View Details
This webinar discusses the concept of conducting an inclusive safety reviews in order to evaluate associated risks and mitigations. Safety axioms appropriate to the safety review concept are discussed.
Speaker: Michael Allocco | View Anytime | Duration: 90 Minutes | Price: $132.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $183.00 | View Details
Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $178.00 | View Details
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities.
Speaker: David R Dills | View Anytime | Price: $154.00 | View Details
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
Speaker: David R Dills | View Anytime | Price: $158.00 | View Details
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.
Speaker: David R Dills | View Anytime | Price: $148.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Price: $155.00 | View Details
Look-up formulas such as VLOOKUP allow you to return data from other locations in your spreadsheets without linking to individual worksheet cells. However, VLOOKUP can't always return the data that you need. In this session Excel expert David Ringstrom, CPA explores the nuances and limitations of VLOOKUP, helps you expand your use of this function, and then leaves you with a handful of alternatives.
Speaker: David Ringstrom | View Anytime | Price: $147.00 | View Details
Many Excel users have a love-hate relationship with workbook links. For the uninitiated, workbook links allow you to connect one Microsoft Excel spreadsheet to other spreadsheets, Word documents, databases, and even web pages.
Speaker: David Ringstrom | View Anytime | Price: $144.00 | View Details
Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.
Speaker: David Ringstrom | View Anytime | Price: $145.00 | View Details
Hazard analysis and risk assessment are powerful tools on hand for safety professionals. With additional knowledge of concepts and axioms an analysts should be able to apply these tools effectively.
Speaker: Michael Allocco | View Anytime | Duration: 90 Minutes | Price: $133.00 | View Details
Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized.
Speaker: Dr. Michael Forstner | View Anytime | Price: $146.00 | View Details
This webinar provides a brief history of the Bayh-Dole Act, where it is managed within the federal government, the invention reporting requirements of grantees to the federal government, an example of how a university coordinates invention reporting requirements to complete timely reporting requirements of the Act. In addition to those provisions that apply to all organizations, non-profit organizations are subject to three obligations that those that seek intellectual property rights via license contracts need to be aware of.
Speaker: Ronald Kudla | View Anytime | Price: $131.00 | View Details
Overview of the different licenses for sites involved with exporting, importing and manufacturing of drugs, natural health products and medical marijuana to be provided. Specific focus will be on which information is required for the various types of facility licenses, for both Canadian and non-Canadian buildings involved in the pharmaceutical product supply chain. Sourcing of active pharmaceutical ingredient sources (API) must now be covered in some types of licensing, details will be provided on API requirements with examples using Health Canada’s required application forms.
Speaker: Karen Friedman | View Anytime | Price: $143.00 | View Details
Effective sanitation in the food industry involves the maintenance of clean conditions in the entire food operation including the control of pests such as cockroaches, houseflies, rats, mice, and birds. This status is attained through the prevention of pest entry and eradication of those that infiltrate food establishments.
Speaker: Norman G. Marriott | View Anytime | Price: $124.00 | View Details
The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $135.00 | View Details
Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $143.00 | View Details
The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $141.00 | View Details
This webinar will cover the major issues facing housing with an emphasis on single-family new residential construction. Coverage will include discussion regarding the preference for owning vs. renting, availability of credit for residential purchases by the consumer and for developers, and availability of labor for residential construction.
Speaker: Bernard Markstein | View Anytime | Price: $139.00 | View Details
This webinar will cover the major issues facing the multifamily housing market with an emphasis on the outlook for new construction. Coverage will include discussion regarding the preference for owning vs. renting, availability of credit for residential purchases by the consumer and for developers, the direction and speed of change in interest rates, the outlook for multifamily condominium units, and availability of labor for construction.
Speaker: Bernard Markstein | View Anytime | Price: $127.00 | View Details
An Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.
Speaker: Elisa Harvey | View Anytime | Price: $132.00 | View Details
This webinar will provide a detailed discussion of understanding the scope of the pre-submission process, what information to provide in a pre-submission, how to prepare for a pre-submission interaction with FDA and how to follow up with FDA following a pre-submission interaction. To do this it will primarily reference the guidance document on pre-submissions recently finalized and issued by FDA earlier this year.
Speaker: Elisa Harvey | View Anytime | Price: $131.00 | View Details
Biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. This webinar will cover the FDA's existing and recently updated draft guidance on the use of ISO-10993 to determine what testing is necessary, and describe in detail general and specific testing considerations, based on the nature and duration of contact of the medical device with humans.
Speaker: Elisa Harvey | View Anytime | Price: $189.00 | View Details
Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.
Speaker: Anne Tomalin | View Anytime | Price: $189.00 | View Details
It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made. Examples of shared experiences with orphan drugs, cough and cold medications, generic drugs and GMP inspections.
Speaker: Anne Tomalin | View Anytime | Price: $189.00 | View Details
This topic will cover the regulatory submission required in Canada (Clinical Trial Application) and comparison to Clinical Trial Applications in Europe and Investigational New Drug Submissions in the EU. Also covered will be the submission of documentation to Institutional Review Boards, the membership of these boards, and common findings of deficiencies for such Boards. Again, a comparison will be made to the US and EU.
Speaker: Anne Tomalin | View Anytime | Price: $127.00 | View Details
This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Speaker: Anne Tomalin | View Anytime | Price: $126.00 | View Details
This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.
Speaker: Anne Tomalin | View Anytime | Price: $127.00 | View Details
FDA's bioresearch monitoring program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas.
Speaker: Thomas E. Colonna | View Anytime | Price: $189.00 | View Details
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Speaker: Thomas E. Colonna | View Anytime | Price: $189.00 | View Details
Why are we concerned about microbiology and what has it to do with the manufacture and sale of consumer products What are bacteria, yeasts and fungi? How can the presence of microorganisms pose a threat to the manufacture of qualify products? More simply stated, what are the characteristics of these organisms, where are they found? Now can such organisms affect our products?
Speaker: Neal Machtiger | View Anytime | Price: $189.00 | View Details
This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.
Speaker: Heath Rushing | View Anytime | Price: $189.00 | View Details
This course will focus on teaching how to efficiently and effectively apply recommended statistical methods and tools to process validation. Using hands-on exercises (complete with realistic process data), participants will learn how to apply these tools, interpret results, and draw meaningful conclusions throughout Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Speaker: Heath Rushing | View Anytime | Price: $189.00 | View Details
Business Continuity Management (BCM) is a holistic management process that identifies potential impacts that threaten an Organization and provides a framework for building resilience with the capability for an effective response that safeguards the interests of its key stakeholders, reputation, brand and value creating activities. This encompasses the management of recovery or continuity in the event of a disaster as well as the management of the overall program through training, rehearsals, and reviews, to ensure the plan stays current and up to date.
Speaker: Ms. Michael Redmond | View Anytime | Price: $149.00 | View Details
Session covers the Business Continuity Management (BCM) and Disaster Recovery (DR)Process or Function, including resilience strategies, recovery objectives, business continuity and crisis management plans and including obtaining management support and organizing and managing the formulation of the function or process either in collaboration with, or as a key component of, an integrated risk management initiative.
Speaker: Ms. Michael Redmond | View Anytime | Price: $138.00 | View Details
Attacker's attack 24x7 and Computer Security Incident Response for a company, government agency or organization must also be ready 24X7. Both reporting incidents and disseminating incident-related information correctly is a must.
Speaker: Ms. Michael Redmond | View Anytime | Price: $149.00 | View Details
An introductory overview will begin the webinar providing tools for clarifying the different types of consumer health products available and regulated in Canada, including drugs, cosmetics, natural health products and health foods. This introduction will include a brief discussion on the acceptable package claims for each type of product, and permissible label statements.
Speaker: Karen Friedman | View Anytime | Price: $149.00 | View Details
Detailed overview of product license applications required for sale of dietary supplement products in Canada. For dietary supplements the requirements list set out by the Natural Health Product Directorate of Health Canada must be followed to a 't'. Any incomplete applications will be refused.
Speaker: Karen Friedman | View Anytime | Price: $149.00 | View Details
AS9100 was released in 1999, and was based on ISO 9001. As many different organizations wanted a standard for their industry, ISO 9001 did not cover all of the aspects needed to ensure safe materials and manufactured goods were acceptable for their aerospace applications.
Speaker: Jason Teliszczak | View Anytime | Price: $149.00 | View Details
The FDA conducts various types of inspections depending on what the firm is doing. Inspections follow fairly predictable patterns. You can identify what factors are relevant for your inspections and how the FDA will work with them. The goal of the seminar is to help you figure out what is relevant for how FDA looks at you. Establishing a well-reasoned inspectional strategy on the basis of relevant FDA factors, and how an inspection unfolds, you avoid or mitigate unnecessary policies and procedures that are premised on a defensive stance or an ad hoc management style, which is usually so anxiety laden that the firm becomes its own worst enemy.
Speaker: Casper Uldriks | View Anytime | Price: $189.00 | View Details
This webinar will address the complexity of defining safe food. We will look at the changing nature of foodborne/food transmitted pathogens, new and emerging analytical technologies and the influence of demographics and geography on the changing landscape.
Speaker: Michael Brodsky | View Anytime | Price: $149.00 | View Details
Social media has become a primary vehicle for reaching buyers, both professional healthcare providers and consumers. The consumers can post whatever they wish, whether it is true, false, an opinion or simply as a joke.
Speaker: Casper Uldriks | View Anytime | Price: $189.00 | View Details
A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines. What must a documentation system look and feel like to ensure compliance?
Speaker: Jason Teliszczak | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
The most important and egregiously written construction contract clauses have been shown to cost a 20% premium on prices and lead to fail projects and litigation. What are examples of poorly drafted killer clauses and how can you avoid them to get better project results.
Speaker: Brian Perlberg | View Anytime | Price: $149.00 | View Details
New regulations are going to dramatically increase banking charges and exporters are going to be impacted more than most.
Speaker: Buddy Baker | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
ISO panning helps you mitigate in a disaster against loss of business, loss of monies, penalties, legal liabilities, loss of reputation, loss of customers and more.
Speaker: Ms. Michael Redmond | View Anytime | Price: $149.00 | View Details
An organization's security policy and controls must be adaptable to emerging threats in today's world. The assessment of security threats is ongoing, and must be mapped against the adequacy and existence of security controls. Security controls and countermeasures that are currently in in place may not commensurate with potential risks. The effort is never ending, but knowing how to start is the key.
Speaker: Ms. Michael Redmond | View Anytime | Price: $149.00 | View Details
The number of medical device recalls was up 28% in 2013 and estimated to be even higher in 2014. Learning to design for durability using risk analysis tools the right way at right time can eliminate many life cycle costs such as production rejects, rework, warranty costs, safety litigation costs, and maintenance and repair costs to customers. Learn how to design it right the first time for not only long life design but understand that no safety related failures should occur during the long life.
Speaker: Dev Raheja | View Anytime | Price: $128.00 | View Details
The Failure Mode Effects Analysis breaks down the analysis of complex software functions into manageable subsystems and modules. It can have a number of variations which address different aspects of the device.
Speaker: Dev Raheja | View Anytime | Price: $189.00 | View Details
This session will raise awareness of fraud issues in Accounts Payable and examine processes to mitigate the risk associated with Accounts Payable to comply with SOX. It will provide you with the tools you need to establish and maintain strong internal controls that meet Sarbanes-Oxley standards by reducing risk and protecting company assets.
Speaker: Mike Morley | View Anytime | Price: $124.00 | View Details
Real world examples of what to expect, and what to prepare for whenever possible. Not every organization is ready to avoid inspections or fines if they do not have senior staff in place, and/or if they have not been audited in the past.
Speaker: Jason Teliszczak | View Anytime | Price: $127.00 | View Details
Since the Food Safety Modernization Act of 2010 became live in 2011 and the Global Food Safety Initiative (GFSI) began gaining significant ground since 2012, certification is now key to gain and maintain clients as well as ensure compliance. These requirements and mandates push every organization to ensure that they are up to date on their food safety programs. With the associated costs related to oversights and recalls, certification to food safety is an important economic aspect of any organization.
Speaker: Jason Teliszczak | View Anytime | Price: $149.00 | View Details
Since the Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and must be adhered to. These requirements mandate FDA’s action in the area of Food Defense, and penalties continue to go higher and higher. With the associated costs related to oversights and recalls, Food Defense is an important economic aspect of any organization.
Speaker: Jason Teliszczak | View Anytime | Price: $149.00 | View Details
Attend this presentation and find out what the SEC is watching closely for now and into the future. Like it or not, the SEC is still fining companies and filing criminal charges against company executives. Don’t be one of them.
Speaker: Mike Morley | View Anytime | Price: $149.00 | View Details
As a finance or accounting professional, you should be familiar with exactly what these IFRS standards for Extractive Industries consist of, and what they mean for companies in the oil, gas and mining industries. This webinar will help you become acquainted with the latest information regarding IFRS for companies in the resource sector.
Speaker: Mike Morley | View Anytime | Price: $149.00 | View Details
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.
Speaker: Jonathan M. Lewis | View Anytime | Price: $189.00 | View Details
Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.
Speaker: Jonathan M. Lewis | View Anytime | Price: $189.00 | View Details
Companies face many common issues or confusions that arise while creating a validation program such as, Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ). Sometimes matrix approach to cleaning validation has gaps or even worse customer or 483 audit findings due to the program's near impossibility to manage. How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program?
Speaker: Jonathan M. Lewis | View Anytime | Price: $189.00 | View Details
You'll not only learn how to control a user's actions, but you'll also learn how to make your spreadsheets as future-proof as possible. You'll also learn techniques that can significantly save you time when making a spreadsheet as "user-proof" as possible.
Speaker: David Ringstrom | View Anytime | Price: $149.00 | View Details
You've likely experienced the "blur" that sets in when you're working in a large spreadsheet. Or the frustration in tasks that consume far more time in Excel than you feel they should.
Speaker: David Ringstrom | View Anytime | Price: $149.00 | View Details
The gluten-free market is one of the fastest growing markets worldwide. For the 18 million Americans who suffer from gluten intolerance, gluten sensitivity or celiac disease, gluten - free products are a necessity. To help assure customer confidence, the FDA issued a final rule in August 5, 2014 that defines gluten - free claims across the food industry. To enforce the final rule FDA may use its full range of routine post- market monitoring activities, including periodic inspections of manufacturer's facilities, food label reviews and gluten analyses of food samples.
Speaker: Rotimi Toki | View Anytime | Price: $149.00 | View Details
Cleaning and sanitation programme are essential to control the hazards of microbiological and physical contamination of foods in the foodservice and food manufacturing facilities. To ensure that a facility and equipment are clean, sanitised and suitable for their intended use, management of the food business must draw up and operate a written sanitation programme and suitable cleaning procedure for all equipment surfaces and structures within the facility.
Speaker: Rotimi Toki | View Anytime | Price: $149.00 | View Details
Attend this webinar to understand the purpose of cleaning validation. The training session will focus on how to develop a cleaning validation plan related to food allergens, including the sequence of events likely to proceed in a cleaning validation plan, which can be tailored for specific situations. Participants will understand what to consider when choosing sampling and testing methods.
Speaker: Rotimi Toki | View Anytime | Price: $189.00 | View Details
Foreign bodies are the most obvious evidence of a contaminated product, its presence in foods is among the biggest source of complaint and prosecution in the food industry. To the food processor or manufacturer, foreign body contamination can be costly and may include the cost of a product recall, legal expenses and ultimately, the costs of lost reputation and consumer confidence.
Speaker: Rotimi Toki | View Anytime | Price: $149.00 | View Details
The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $136.00 | View Details
Reliability Plotting is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for data that is problematic in one or more of the following ways: non-normal (e.g., a Fatigue-Life distribution), a mixture of distributions (e.g., the distribution looks bi-modal when arranged into a histogram), low precision (e.g., a large number of identical readings in a small sample size), and/or incomplete (e.g., when a study is terminated before all on-test devices can be measured, due either to measurement equipment limitations or due to time limitations). Reliability plotting can easily handle all such situations.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
This webinar is designed to help you understand how the new rules for the sanitary transportation of human and animal foods will impact your logistics operations and to provide you with some of the tools needed to meet new regulations and customer demands.
Speaker: John Ryan | View Anytime | Price: $149.00 | View Details
Primary responsibility for food safety lies with the business operator. The increasing expectations from consumers' couple with the demand to detect hazards and sources of foodborne illness, together with implementation of FSMA have the potential of raising the bar in terms of food safety management. HACCP system allows you to predict risks to food safety and prevent them before they happen.
Speaker: Rotimi Toki | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC must be included in the application. In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it. For decisions concerning centralized marketing authorizations, according to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC is addressed and notified to the Marketing Authorization Holder.
Speaker: Adriaan Fruijtier | View Anytime | Price: $121.00 | View Details
Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following advice from the Regulatory Authorities increases the probability of a positive outcome.
Speaker: Adriaan Fruijtier | View Anytime | Price: $189.00 | View Details
Advanced therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration.
Speaker: Adriaan Fruijtier | View Anytime | Price: $189.00 | View Details
The Social Cost of Carbon (SCC) is being used by EPA, NHSTA, and other Federal regulatory agencies to impose a large de-facto carbon tax on the U.S. economy - a tax that the U.S. Congress would never pass.
Speaker: Roger Bezdek | View Anytime | Price: $149.00 | View Details
The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes. For food shippers, carriers and receivers, standardization or upgrade to current practices is critical. For buyers, knowing how to establish standards for your food transporters sets the stage for required supply chain controls.
Speaker: John Ryan | View Anytime | Duration: 75 Minutes | Price: $149.00 | View Details
We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process.
Speaker: Karl Leinsing | View Anytime | Price: $189.00 | View Details
Manual and semi-manual impulse sealing is inherently safe on the production line without continuous heat on the jaws. The sealing can be difficult to validate when factors, beside humans, are not understood and controlled properly. Jan takes you through various factors she has found to effect impulse sealers and to the newer technology that reduces the issues.
Speaker: Jan Gates | View Anytime | Duration: 60 Minutes | Price: $189.00 | View Details
Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall process results based on statistical database for each batch of that product code. Strategies for process control and operator activities can be designed to reduce variation, adjust for variation during manufacturing and reduced possibility for operator error, as well as an overall blend to manage critical process parameters (CPPs) as well as the original process limits which typically change after the initial validation as well as the trend analysis for each critical step of the process.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
FAA Definition: NextGen is the evolution of the NAS to a more advance state, which makes better use of technology and design to more efficiently meet transportation needs.
Speaker: Roger Nakata | View Anytime | Price: $149.00 | View Details
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements. Understand the difference between and 1st and 2nd B-Notice and the related differences in required vendor responses. Be sure you institute and stop Backup Withholding when required.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Are you responsible for payroll or employer tax withholding compliance? Or maybe you were recently hired or promoted into the payroll department. During your indoctrination you are surprised at all the interesting things to do and how important this role is to the success of the company.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $138.00 | View Details
What are the rules regarding paying and IRS reporting on Independent Contractors? How do I avoid the IRS CP-2100 (B-Notices)? What if my vendor claims exemption; must I obtain a W-9 anyway? What are the best practices? How can I minimize risk of improper exemption claims by my vendors? Get the answers to these and related questions to reduce your risk of huge penalties from the IRS.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Join us and you can begin to develop a solid plan to move your company toward sales and use tax compliance. Experienced CPA and businessman, Miles Hutchinson, will review the basics of sales and use taxation with you and answer your questions. He will discuss legal developments in the area of taxation of internet sales. You will receive practical guidance to avoid penalties due to the ever increasing instances of audits by state taxing authorities.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Miles Hutchinson, experienced CPA and financial analyst, will discuss the basic principles of FATCA, the affected businesses and individuals, the new and revised forms to effect compliance and provide you with simplifying charts and tables to help you determine your steps to full compliance. He will provide practical instructions and guidance for applying FATCA and will identify the key issues that will help you avoid potential penalties for noncompliance.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $147.00 | View Details
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
This webinar will discuss the 9 required elements of a Design Control System. It will consider different methods of implementation, and expectations of the U.S. FDA, proven by documentation.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $189.00 | View Details
The largest cause of Product Liability Lawsuits and Recalls comes from "Defects in Design". The product was defective right from the start, but no one caught it in time.
Speaker: Randy Goodden | View Anytime | Price: $149.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820).
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information we are able to help you concentrate your exploration efforts to keep your budget in the black.
Speaker: Ricardo Valls | View Anytime | Price: $189.00 | View Details
On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").
Speaker: Adriaan Fruijtier | View Anytime | Price: $189.00 | View Details
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Speaker: Anna Longwell | View Anytime | Price: $189.00 | View Details
When manufacturing variation is reduced, two good things happen. One is that the consumer’s second product experience is more like the first. This builds consumer confidence and, therefore, repeat sales. The second is fewer production line stoppages and a process flow that is more laminar, less turbulent. Both of these outcomes of Process Variation Reduction (PVR) enhance the financial bottom line.
Speaker: Lynne Hare | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
The field of biological facility design has been one of the most evolving engineering practices over the last 30 years. In the 1980s most biological facilities were modeled after generations of antibiotic production. These were large and suffered with significant bioburden problems.
Speaker: Herman Bozenhardt | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $139.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
Speaker: David R Dills | View Anytime | Duration: 3 Hours | Price: $189.00 | View Details
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Speaker: Steven Walfish | View Anytime | Price: $189.00 | View Details
The identification and arrangement with a contract service provider (CSP) for the manufacture or testing of an early or late stage pharma product provides many opportunities as well as pitfalls. The reasons for turning to a CSP frequently are due to resources, either capital or monetary, headcount or level of expertise, technical capabilities or most commonly TIME. Meeting timelines and doing it right in the development and realization of a pharma product can be at loggerheads with one and another and turning to a CSP can be the answer.
Speaker: Joseph Habarta | View Anytime | Price: $189.00 | View Details
The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the ATCSCC employs to manage and resolve areas of significant traffic congestion and delay.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Miles Hutchinson, will show you how to unlock the power of scroll bars and spinners, goal seek, one and two-input data tables and scenario manager in your models. He will provide you with samples of the tools demonstrated during the webinar along with complete instructions for creating and using each of these tools.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
The best way forward is an efficient Incident Response Program that allows an organization to respond with speed and agility, while empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation.
Speaker: Ms. Michael Redmond | View Anytime | Price: $149.00 | View Details
During 19 years as mineralogist in the mineralogical Laboratory of Anglovaal Limited the speaker was responsible, among other duties, for assisting metallurgical plants with recovery problems. He was able to assist plants that were recovering gold from Paleo placer deposits (Witwatersrand) and Greenstone domains (Barberton Mountain Land). This talk presents the seven most common causes encountered and solutions for most.
Speaker: Hannes Wagner | View Anytime | Price: $149.00 | View Details
As an experienced FDA medical device investigator, many firms have failed to fully incorporate the requirements of 21 CFR 803 when establishing and implementing their reporting procedures.
Speaker: Leo Lagrotte | View Anytime | Price: $189.00 | View Details
As an experienced FDA medical device investigator, at one time or another many firms have failed to incorporate the requirements of 21 CFR 1002 and 21 CFR 1040 when designing and planning to file premarket clearance documents with FDA.
Speaker: Leo Lagrotte | View Anytime | Price: $189.00 | View Details
Normality Tests and normality transformations are a combination of graphical and numerical methods that have been in use for many decades. These methods are essential to apply whenever a statistical test or method is used whose fundamental assumption is that the inputted data is normally distributed.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can we use to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Speaker: Thomas E. Colonna | View Anytime | Price: $189.00 | View Details
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Speaker: Thomas E. Colonna | View Anytime | Price: $189.00 | View Details
Consumer demand for minimally processed products with a longer shelf-life has resulted in the mass production and distribution of chilled convenience RTE foods. However, RTE foods remain a significant vehicle for foodborne pathogens such as Listeria monocytogenes. The challenges are enormous because production of RTE foods frequently involves extensive processing and packaging. Therefore, this webinar is designed to review current knowledge on the pathogens of concern, sources and intervention controls.
Speaker: Rotimi Toki | View Anytime | Price: $149.00 | View Details
Cleaning and sanitation programme are essential to control the hazards of microbiological and physical contamination of foods in the foodservice and food manufacturing facilities. To ensure that a facility and equipment are clean, sanitised and suitable for their intended use, management of the food business must draw up and operate a written sanitation programme and suitable cleaning procedure for all equipment surfaces and structures within the facility.
Speaker: Rotimi Toki | View Anytime | Price: $149.00 | View Details
The gluten-free market is one of the fastest growing markets worldwide. For the 18 million Americans who suffer from gluten intolerance, gluten sensitivity or celiac disease, gluten - free products are a necessity. To help assure customer confidence, the FDA issued a final rule in August 5, 2014 that defines gluten - free claims across the food industry. To enforce the final rule FDA may use its full range of routine post- market monitoring activities, including periodic inspections of manufacturer's facilities, food label reviews and gluten analyses of food samples.
Speaker: Rotimi Toki | View Anytime | Price: $149.00 | View Details
Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.
Speaker: Michael Brodsky | View Anytime | Price: $149.00 | View Details
Many microbiology laboratories are confused about what MU is, how to calculate it and how to apply it. We will discuss what is needed to meet the accreditation requirement for MU, including, what data to collect and how to analyze it. Also a practical step by step approach to data compilation specifically applicable to microbiology will be discussed.
Speaker: Michael Brodsky | View Anytime | Price: $189.00 | View Details
Many laboratories regard Quality Assurance, Quality Assessment and Quality Control as independent activities, others use the terms interchangeably, e.g. QA/QC. This demonstrates a lack of appreciation of the differences between Assurance, Assessment and Control, as well as the interrelationships, particularly between QA and QC. This has created confusion in the minds of many analysts with respect to understanding how QA and QC play separate, but related roles for achieving Quality Assurance in a Quality Management System (QMS). QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005.
Speaker: Michael Brodsky | View Anytime | Price: $189.00 | View Details
As an experienced FDA medical device investigator, approximately 90% of all FDA 483 I've issued contained inspectional observations that included firm's inability to establish and implement Complaint Handling procedures in compliance with 21 CFR 820, or failed to follow their own established procedures. Either way can get a firm into sufficient Warning Letter territory.
Speaker: Leo Lagrotte | View Anytime | Price: $189.00 | View Details
The webinar begins with a brief review of how total construction spending and its major components-private residential, private nonresidential and public construction-fared during the industry’s long slump from 2006 to 2011, and how far each component has recovered to date.
Speaker: Kenneth D. Simonson | View Anytime | Price: $149.00 | View Details
hird party agreements cover everything from cleaning to the provision and operation of strategic information technology systems. From the simplest of services to the most complex, such agreements can bring significant benefits including economies, more effective services than could be delivered in house and expert knowledge and skills. However, this comes at a price: strategic risks and new uncertainties can hide within such agreements.
Speaker: Stuart Gardner | View Anytime | Duration: 60 Minutes | Price: $149.00 | View Details
Every project undertaken is not a guaranteed success; there are many things that can and do go wrong. Overly optimistic budgets or underfunded projects can result in shortcuts or unrealistic pressures on those working on the project. Staff or resources lacking the skills to work on the project see the assignment as a fast track to promotion and may not be willing to admit they can not handle the project, projects escalated to be done quickly may result in shoddy workmanship, resources pulling on time constraints can stretch employees to thin, opposition may even exist that is looking to have the project fail - yes sabotage is more common than many will admit to.
Speaker: Stuart Gardner | View Anytime | Price: $149.00 | View Details
The United Nations Convention Against Corruption was formed as a committee in 2003 to help combat what was being seen as an epidemic against free trade. Organizations working in the international arena now face greater regulatory challenges to continue practicing, to educate their employees, and to monitor for violations. The legal loophole is spreading and the FCPA has recently held financial institutions liable for not reporting clients who fail to comply with FCPA requirements.
Speaker: Denise Cicchella | View Anytime | Price: $149.00 | View Details
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
Speaker: Louis Angelucci | View Anytime | Duration: 60 Minutes | Price: $189.00 | View Details
Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized.
Speaker: Dr. Michael Forstner | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.
Speaker: Jonathan M. Lewis | View Anytime | Price: $189.00 | View Details
Companies face many common issues or confusions that arise while creating a validation program such as, Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ). Sometimes matrix approach to cleaning validation has gaps or even worse customer or 483 audit findings due to the program's near impossibility to manage. How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program?
Speaker: Jonathan M. Lewis | View Anytime | Price: $189.00 | View Details
Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.
Speaker: Jonathan M. Lewis | View Anytime | Price: $189.00 | View Details
Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. Proper Environmental Cleaning is just as important as the cleaning of the "inside" of food processing equipment. The exterior of equipment, floors, walls, ceilings, doorways and drains can be a major source of microbial contamination if not properly controlled.
Speaker: Donald Jones | View Anytime | Price: $149.00 | View Details
Industrial Technical Benefits- Canada's new approach to offsets for defence procurement: As part of the recently announced Defence Procurement Strategy, the Canadian Government has introduced a new industrial benefits policy that is designed to leverage purchases of defence equipment to create jobs and economic growth in Canada. Companies pursuing defence procurement opportunities in Canada will be required to submit value propositions, include key industrial capabilities (KIC) in their proposal and submit detailed industrial and technological benefits (ITB) plans with their proposals that will then be rated by the Government.
Speaker: Anthony Goode | View Anytime | Duration: 75 Minutes | Price: $149.00 | View Details
The webinar will provide an introduction to the Controlled Goods Program such that the participants will understand the requirements for the program, its legislative and policy foundation as well as the process for obtaining certification and compliance with the policy. Controlled Goods Program (CGP) -a domestic industrial security program.
Speaker: Anthony Goode | View Anytime | Duration: 75 Minutes | Price: $149.00 | View Details
Evaporation Ponds are used throughout the nation for various purposes. The Oil & Gas industry uses this methodology to separate out hydrocarbons and dispose of the large amounts of process water from operations. With the purpose of evaporation in mine, even small operations are finding out they can be classified as Major Source. Several other types of permits and plans may also apply to "evap ponds".
Speaker: Erin Hallenberg | View Anytime | Price: $149.00 | View Details
This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Air Route Traffic Control Center (ARTCC). The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
In financial institution, operational risk has been considered as minor compared to credit risk and market risk. Moreover, Operational Risk is too difficult to grasp for bankers. Therefore operational risk management is often considered as a regulatory constraint or as an imprecise practice rather than a science, and it is often hijacked by political necessities, or can turn into insignificant exercises aimed at predicting small losses or improving efficiency without consideration for high-impact risks.
Speaker: Fred Vacelet | View Anytime | Price: $149.00 | View Details
This webinar provides a detailed look at recent trends and outlook for construction spending, materials costs and employment, nationally and by state. Rather than treating construction as a single industry or a simple split between residential and nonresidential, the webinar delves into the sharply differing trends and future drivers for single- and multifamily residential construction, 10 categories of private nonresidential construction, and the leading public categories-highway & street and educational, both K-12 and higher.
Speaker: Kenneth D. Simonson | View Anytime | Price: $149.00 | View Details
Companies must provide effective chemical safety training for all employees including managers, supervisors, operators and temporary workers. The objective of this presentation is to equip the participants with the basic skills and knowledge to assess chemical hazards in their workplace. The participants will also be presented with basic controls for working safely with chemical detergents and sanitizers used in food processing plants.
Speaker: Donald Jones | View Anytime | Price: $149.00 | View Details
Research resources are too scarce to be squandered going down blind alleys and coming up empty handed at project end. We can no longer afford to play hunches or to rely on so called experts, whose opinions all differ, to guide research. Nor can we rely on the gross inefficiencies of old-fashioned one-factor-at-a-time experimentation to guide decisions. Instead, R&D must proceed systematically and with a goal of using unbiased data to guide decisions, following an overall strategy guided by statistical thinking and the scientific method.
Speaker: Lynne Hare | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
Speaker: Jeff Kasoff | View Anytime | Price: $189.00 | View Details
A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program.
Speaker: Jeff Kasoff | View Anytime | Price: $189.00 | View Details
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Speaker: Jeff Kasoff | View Anytime | Price: $189.00 | View Details
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.
Speaker: Jeff Kasoff | View Anytime | Price: $189.00 | View Details
Individuals responsible for medical packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end-user without incurring defect or risk to patient safety.
Speaker: Karen Greene | View Anytime | Price: $189.00 | View Details
The webinar covers factors considered by FDA before, during and after an inspection that can be used to predict your inspectional vulnerability. Once you know some key points, you will see that FDA's approach to inspections follows well-established procedures and risk criteria that enables FDA to characterize your firm's compliance. Usually the only way FDA will let you know about your profile is when an official action is indicated. That is not a good thing. Otherwise, you hear very little and even then, you may wait a long time. The cloud of doubt can plague a firm for months.
Speaker: Casper Uldriks | View Anytime | Price: $189.00 | View Details
The FDA Form 483 represents an inspectional record of objectionable conditions observed by the FDA investigator during an inspection of a manufacturing establishment. The inspection will cover a certain set of regulations that apply to the particular manufacturer's operations. Products regulated by FDA have different manufacturing, records and reporting regulations.
Speaker: Casper Uldriks | View Anytime | Price: $189.00 | View Details
This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs. It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made.
Speaker: Anne Tomalin | View Anytime | Price: $189.00 | View Details
This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.
Speaker: Anne Tomalin | View Anytime | Price: $189.00 | View Details
This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Speaker: Anne Tomalin | View Anytime | Price: $189.00 | View Details
We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork.
Speaker: Karl Leinsing | View Anytime | Price: $189.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Some products in specific industries, such as consumer products, automotive, food and pharmaceutical have to be designed and manufactured in compliance to that industry's regulatory requirements, which is wrongly viewed as the only safety requirement the manufacturer needs to really focus on in design, but such regulatory requirements offer no guarantee or assurance that the product is then 'safe'.
Speaker: Randy Goodden | View Anytime | Duration: 60 Minutes | Price: $149.00 | View Details
Protecting the manufacturing corporation from product liability lawsuits isn't just about product design and engineering, it involves the activities in a number of different management areas from the CEO down to the lowest levels of management. In this segment we will identify each of those individual areas, what could be going wrong and unnoticed, and how to prevent such exposure to liability.
Speaker: Randy Goodden | View Anytime | Price: $149.00 | View Details
Many companies use attribute sampling plans at incoming, in-process, and final inspection. The common approach uses ANSI/ASQ Z1.4. There is an alternate, however, that may reduce cost. Sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement.
Speaker: Dan OLeary | View Anytime | Duration: 75 Minutes | Price: $189.00 | View Details
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
There exists apparent financial auditor (FA) and IT auditor responsibility overlaps. One reason this interrelationship exists is because, when planning audits, the FA and IT auditor evaluate manual as well as automated processing.
Speaker: Robert E. Davis | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $189.00 | View Details
When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
Speaker: David R Dills | View Anytime | Price: $189.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.
Speaker: Robert Kunka | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Attend this webinar to have a clear understanding of what information should be on a label.The training session will dwell extensively on the ten legally bound things on the list of information which labelling laws say must be included on most foods. Participants would be shown with practical examples how to calculate Quantitative Ingredient Declaration (QUID), when to apply it and when it is inappropriate for use.
Speaker: Rotimi Toki | View Anytime | Price: $149.00 | View Details
Foreign bodies are the most obvious evidence of a contaminated product, its presence in foods is among the biggest source of complaint and prosecution in the food industry. To the food processor or manufacturer, foreign body contamination can be costly and may include the cost of a product recall, legal expenses and ultimately, the costs of lost reputation and consumer confidence.
Speaker: Rotimi Toki | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
This webinar will provide a detailed discussion of understanding the scope of the pre-submission process, what information to provide in a pre-submission, how to prepare for a pre-submission interaction with FDA and how to follow up with FDA following a pre-submission interaction. To do this it will primarily reference the guidance document on pre-submissions recently finalized and issued by FDA earlier this year.
Speaker: Elisa Harvey | View Anytime | Price: $189.00 | View Details
This webinar will provide a detailed discussion of understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (RFD) and how to work with FDA when submitting applications for combination products. To do this it will reference the extensive information provided by FDA’s Office of Combination Products.
Speaker: Elisa Harvey | View Anytime | Price: $189.00 | View Details
This webinar provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations.
Speaker: Albert A. Ghignone | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Speaker: David R Dills | View Anytime | Price: $189.00 | View Details
There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.
Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
Speaker: Dan OLeary | View Anytime | Duration: 75 Minutes | Price: $189.00 | View Details
In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.
Speaker: Thomas E. Colonna | View Anytime | Price: $189.00 | View Details
Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: $189.00 | View Details
The course also covers recent updates on EU GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.
Speaker: David R Dills | View Anytime | Price: $189.00 | View Details
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.
Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
We will cover several topics of value to food manufacturing sanitation team members. We will begin with a conceptual understanding of cleaning vs. sanitation.
Speaker: Melinda Allen | View Anytime | Price: $189.00 | View Details
When working with contract testing laboratories, clients must remember that the responsibility for compliance with the GMP or the GLP ultimately lies with the product sponsor. Even if the contract assignes the responsibility to the contract laboratory, the responsibility for assuring compliance lies with the client. Neither can the contract laboratory assume that the client has complied with their responsibilities.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $189.00 | View Details
High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $189.00 | View Details
Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
Speaker: David R Dills | View Anytime | Price: $189.00 | View Details
This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.
Speaker: Heath Rushing | View Anytime | Price: $189.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
The most important and egregiously written construction contract clauses have been shown to cost a 20% premium on prices and lead to fail projects and litigation. What are examples of poorly drafted killer clauses and how can you avoid them to get better project results.
Speaker: Brian Perlberg | View Anytime | Price: $149.00 | View Details
Even though the present government committed to increasing defence spending, the reality of reducing the deficit incurred during the financial crisis has affected every part of government including National Defence. In order to understand the impact of the various spending reduction exercises on DND, it is essential to be aware of the background to the current budget situation, which offers some key insights.
Speaker: Anthony Goode | View Anytime | Price: $149.00 | View Details
Hourly Cost Maintenance Programs (HCMP) were originally introduced by the engine and airframe OEMs to demonstrate their confidence in the cost to maintain their product. Today, these Programs have become a near staple for many aircraft, to the point where the value for many assets is negatively impacted absent HCMP coverage.
Speaker: Anthony Kioussis | View Anytime | Price: $149.00 | View Details
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
This webinar provides a detailed look at recent trends and outlook for construction spending, materials costs and employment, nationally and by state. Rather than treating construction as a single industry or a simple split between residential and nonresidential, the webinar delves into the sharply differing trends and future drivers for single- and multifamily residential construction, 10 categories of private nonresidential construction, and the leading public categories-highway & street and educational, both K-12 and higher.
Speaker: Kenneth D. Simonson | View Anytime | Duration: 60 Minutes | Price: $149.00 | View Details
This webinar provides a detailed look at recent trends and outlook for construction spending, materials costs and employment, nationally and by state. Rather than treating construction as a single industry or a simple split between residential and nonresidential, the webinar delves into the sharply differing trends and future drivers for single- and multifamily residential construction, 10 categories of private nonresidential construction, and the leading public categories-highway & street and educational, both K-12 and higher.
Speaker: Kenneth D. Simonson | View Anytime | Price: $149.00 | View Details
This webinar, one in a series of ATC topics, addresses the operational environment and functioning of ATC System Command Center (ATCSCC). The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the ATCSCC employs to manage and resolve areas of significant traffic congestion and delay.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Air Route Traffic Control Center (ARTCC). The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Airport Traffic Control Tower (ATCT). The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
This webinar was created to review the basics of Hazard Analysis and Critical Control Points (HACCP) plans and propose ideas for business uses of this tool. Product design and profiling are a few of the areas where this tool can be applied. Because these and other applications can have economic impact in the business the idea of this webinar was to review how we can facilitate the analysis and decision making of individual situations with this tool.
Speaker: Rodriguez Gonzalez | View Anytime | Duration: 60 Minutes | Price: $149.00 | View Details
Miles Hutchinson, experienced CPA and financial analyst, will discuss the basic principles of policy and procedure design, how to plan a project, including a detailed project budget, how to write clear and concise standards, how to obtain senior management approval of your policies and procedures, how to ensure compliance with those procedures, and the most efficient way to keep your processes up-to-date. He will provide practical instructions and guidance for testing the quality of your accounting procedures.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
The webinar will provide an introduction to the Controlled Goods Program such that the participants will understand the requirements for the program, its legislative and policy foundation as well as the process for obtaining certification and compliance with the policy. Controlled Goods Program (CGP) -a domestic industrial security program.
Speaker: Anthony Goode | View Anytime | Price: $149.00 | View Details
Learn the rules requiring W-9 documentation and 1099 reporting. Learn how to establish the independent contractor relationship with the right documentation. Understand the rules and keep your company in compliance. Ensure that your records will stand the scrutiny of an IRS 3rd Party Documentation and Reporting audit. Avoid the onerous penalties for noncompliance and build the best defense against the 972-CG Notice of Proposed Penalty Letter.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Fraud and abuse losses continue to significantly impact as many as 70% of businesses, governments and non-profits annually. Purchases (from large projects to minor daily expenses) can represent as much as 60% of an organization's spending and provides those looking to steal and defraud an attractive target.
Speaker: Ray Kulzick | View Anytime | Price: $149.00 | View Details
Although steadily expanding for years before Enron, Worldcom and other major frauds in the early 2000s brought the concept into the public's consciousness, the field of forensic accounting has seen rapid growth since then. This growth has steadily increased the areas where forensic accountants can be utilized far beyond just fraud investigations into almost any area where money or other "numbers" are related to the issues in a case.
Speaker: Ray Kulzick | View Anytime | Price: $149.00 | View Details
Learn how to create and ISO 22301program to plan, establish, implement, operate, monitor, review, maintain and continually improve a documented management system to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from disruptive incidents when they arise.
Speaker: Ms. Michael Redmond | View Anytime | Price: $149.00 | View Details
The Defence Procurement Strategy announced in February 2014 is designed to address many of the problems that have plagued defence procurement policy for many years. It includes changes in responsibility, changes in the Industrial Regional Benefits Policy and changes in the way in which proposals are prepared and evaluated. This webinar will explain the DPS in detail and will brief participants on the major defence procurements planned over the next few years including programs for the Air Force, Navy, Army and Coast Guard.
Speaker: Anthony Goode | View Anytime | Duration: 75 Minutes | Price: $149.00 | View Details
National Shipbuilding Procurement Strategy is a fundamental shift in the way that the Federal Government in Canada procures major ships for the Navy and the Coast Guard. Shipbuilding policy has been in a state of flux for many years as has ship procurement with many prolonged and in some cases failed procurements.
Speaker: Anthony Goode | View Anytime | Price: $149.00 | View Details
Small business owners and startup companies often lack the resources to hire someone to properly set up their accounting system and their policies and procedures. They often don't know what they can and cannot deduct and, even if they do, they are unsure of the proper documentation requirements. In this webinar, we will give you a solid foundation to build your accounting system on so that you can maximize your deductions and minimize any problems with the Internal Revenue Service.
Speaker: Reuven Rubinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
This webinar, one in a series of ATC topics, addresses the operational environment and functioning of ATC System Command Center (ATCSCC). The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the ATCSCC employs to manage and resolve areas of significant traffic congestion and delay.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Air Route Traffic Control Center (ARTCC). The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Airport Traffic Control Tower (ATCT). The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
The best way forward is an efficient disaster recovery solution that helps respond with speed and agility, while empowering businesses to maintain continuous operations during an outage. Such a solution also ensures availability of critical systems, reduces revenue loss, and protects brand reputation. : Emergency Planning, Business Continuity Planning and Crisis Management.
Speaker: Ms. Michael Redmond | View Anytime | Price: $149.00 | View Details
Managing without measuring is like navigating without destination. Performance indicators are utilized by managers to track and evaluate progress towards their goals. Indicators of compliance with regulations can be easily integrated into management systems and assist with self-assessment. The goal of this webinar is to review the use of metrics to manage compliance issues and prevent conflicts before they occur. Fundamental concepts, ideas and examples will be reviewed.
Speaker: Rodriguez Gonzalez | View Anytime | Price: $149.00 | View Details
Adhering to rules is essential to protect your business against compliance risks. For a business whose reason of being in the market is to generate profit for its shareholders this may represent a loss in earnings and lead to deceptive practices that are considered fraud. The objective of this webinar is to analyze basic concepts around the issue of compliance using a business perspective, explore alternatives to minimize the costs of compliance and to provide some examples on how these ideas are applied in the food and beverage sector.
Speaker: Rodriguez Gonzalez | View Anytime | Price: $149.00 | View Details
Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. Proper Environmental Cleaning is just as important as the cleaning of the "inside" of food processing equipment. The exterior of equipment, floors, walls, ceilings, doorways and drains can be a major source of microbial contamination if not properly controlled.
Speaker: Donald Jones | View Anytime | Price: $149.00 | View Details
Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
We will begin with the methods of identifying workers who may be non-resident aliens and proceed to the forms and methods of collecting the necessary information to determine whether back-up withholding is required. Next we will examine the rules and forms for proper depositing of back-up withholding taxes and the required reporting to the worker as well as to the IRS. Please note, beginning in 2014 the number and complexity of the forms have both increased due to the implementation of FATCA, the Foreign Accounts Tax Compliance Act.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. The objective of this presentation is to equip the participants with the basic skills and knowledge to properly perform a titration drop count test on food plant chemical cleaners and sanitizers. The participants will also be presented with a basic review of the most common single parameter titration test kits used on chemical detergents and sanitizers.
Speaker: Donald Jones | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
When manufacturing variation is reduced, two good things happen. One is that the consumer’s second product experience is more like the first. This builds consumer confidence and, therefore, repeat sales. The second is fewer production line stoppages and a process flow that is more laminar, less turbulent. Both of these outcomes of Process Variation Reduction (PVR) enhance the financial bottom line.
Speaker: Lynne Hare | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Industrial Technical Benefits- Canada's new approach to offsets for defence procurement: As part of the recently announced Defence Procurement Strategy, the Canadian Government has introduced a new industrial benefits policy that is designed to leverage purchases of defence equipment to create jobs and economic growth in Canada. Companies pursuing defence procurement opportunities in Canada will be required to submit value propositions, include key industrial capabilities (KIC) in their proposal and submit detailed industrial and technological benefits (ITB) plans with their proposals that will then be rated by the Government.
Speaker: Anthony Goode | View Anytime | Price: $149.00 | View Details
FAA Definition: NextGen is the evolution of the NAS to a more advance state, which makes better use of technology and design to more efficiently meet transportation needs.
Speaker: Roger Nakata | View Anytime | Price: $149.00 | View Details
Every project undertaken is not a guaranteed success; there are many things that can and do go wrong. Overly optimistic budgets or underfunded projects can result in shortcuts or unrealistic pressures on those working on the project. Staff or resources lacking the skills to work on the project see the assignment as a fast track to promotion and may not be willing to admit they can not handle the project, projects escalated to be done quickly may result in shoddy workmanship, resources pulling on time constraints can stretch employees to thin, opposition may even exist that is looking to have the project fail - yes sabotage is more common than many will admit to.
Speaker: Stuart Gardner | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Airport effectiveness is dependent on each airport entity’s participation and effectiveness at the airport. When information is not shared or understood by even one entity, it creates safety and efficiency issues at the airport. Whether you are an Airline, Airport Operations, Airport Manager, Air Traffic Control or any other entity on the airport, you must have a complete understanding of your requirements of the operations at the airport. You must have a good understanding of the needs and requirements of the other entities. Ignorance and misunderstandings compromises safety and decreases the efficiency at the airport.
Speaker: Roger Nakata | View Anytime | Price: $149.00 | View Details
Join us for 90 minutes to learn how to put the powerful sensitivity tools of Microsoft Excel to work in your models. Learn the top 20 best practices of solid model design, development and delivery. Seasoned financial analyst, Miles Hutchinson, will show you how to unlock the power of scroll bars and spinners, goal seek, one and two-input data tables and scenario manager in your models. He will provide you with samples of the tools demonstrated during the webinar along with complete instructions for creating and using each of these tools.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Many people believe that communications, navigation, surveillance, and automation technologies are the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely. In reality, air traffic control is the process by which many thousands of airplanes are provided separation services as they climb, descend, and cross paths and altitudes as they travel from any one of thousands of departure airports to any one of thousands of destination airports daily.
Speaker: Stephen Alvania | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Today we are not dealing with a system. We are dealing with system-of-systems. Safety has become too complex with millions of lines of codes in hardware components and interoperability risks of such components. Not only design engineers should have this knowledge but every technical employee and every manager must have thorough knowledge of the science of system safety.
Speaker: Dev Raheja | View Anytime | Price: $149.00 | View Details
In financial institution, operational risk has been considered as minor compared to credit risk and market risk. Moreover, Operational Risk is too difficult to grasp for bankers. Therefore operational risk management is often considered as a regulatory constraint or as an imprecise practice rather than a science, and it is often hijacked by political necessities, or can turn into insignificant exercises aimed at predicting small losses or improving efficiency without consideration for high-impact risks.
Speaker: Fred Vacelet | View Anytime | Price: $149.00 | View Details
The United Nations Convention Against Corruption was formed as a committee in 2003 to help combat what was being seen as an epidemic against free trade. Organizations working in the international arena now face greater regulatory challenges to continue practicing, to educate their employees, and to monitor for violations. The legal loophole is spreading and the FCPA has recently held financial institutions liable for not reporting clients who fail to comply with FCPA requirements.
Speaker: Denise Cicchella | View Anytime | Price: $149.00 | View Details
Foodservice sanitation is the maintenance of clean conditions in food production, preparation, and serving areas as well as the practice of proper personal cleanliness and hygienic practices. As the foodservice industry has grown, methods of food production, processing, distribution, and preparation have changed. Major changes have included increased prepackaged food as partially or fully prepared bulk or pre-portioned servings and centralized food production.
Speaker: Norman G. Marriott | View Anytime | Price: $149.00 | View Details
Meeting regulatory specifications is the minimum that a business needs to get done to operate in a market without falling in the risk of non-compliance. This type of requirements are analog to those required by the customers, and the Continual Improvement tools used for quality control are interchangeable. The idea of this webinar is to provide a visualization of regulatory requirements from a Continual Improvement angle. Ideas and examples of how Continual Improvement tools can be utilized to facilitate the management of regulatory issues will be provided.
Speaker: Rodriguez Gonzalez | View Anytime | Duration: 60 Minutes | Price: $149.00 | View Details
Miles Hutchinson, experienced CPA and financial analyst, will discuss the basic principles of FATCA, the affected businesses and individuals, the new and revised forms to effect compliance and provide you with simplifying charts and tables to help you determine your steps to full compliance. He will provide practical instructions and guidance for applying FATCA and will identify the key issues that will help you avoid potential penalties for noncompliance.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Gain valuable insight into the complex issues of interstate sales and the obligations of out-of-state (foreign) sellers to collect the destination state’s taxes. Get up-to-date information about the retailing giants and their fights with the various states. Take a ring-side seat with an expert who will share the anticipated outcomes.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Join us and you can begin to develop a solid plan to move your company toward sales and use tax compliance. Experienced CPA and businessman, Miles Hutchinson, will review the basics of sales and use taxation with you and answer your questions. He will discuss legal developments in the area of taxation of internet sales. You will receive practical guidance to avoid penalties due to the ever increasing instances of audits by state taxing authorities.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View DetailsTopic: Not Specified
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