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.
This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.
Advancements in technology have forced organizations to rethink business models.
Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.
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.
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 will begin by defining value stream mapping and the key terms that comprise the VSM process.
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.
Advancements in technology have forced organizations to rethink business models.
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.
Microsoft Excel has become the de facto spreadsheet application for business.
This 90-minute webinar offers a comprehensive exploration of the fundamental principles and practical applications of user-centered design (UCD) within the realm of pharmaceuticals and medical device development.
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.
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.
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"
Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy.
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Data protection and privacy is an important issue this day and age for the public.
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
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.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Verification and validation of design inputs is a critical step in the development of medical devices.
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
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.
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.
Verification and validation of design inputs is a critical step in the development of medical devices.
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
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.
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.
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.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
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.
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.
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
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.
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.
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
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.
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.
Assessment of the cause for a non-compliance is a structured series of branching questions.
This easy to follow demonstration clearly explains how to effectively post ChatGPT questions on more advanced Excel topics and extract more accurate responses.
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.
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.
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.
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
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.
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?
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
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.
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.
In today's world, there are a ton of data to manage. Data is coming from many different sources.
Microsoft Excel has become the de facto spreadsheet application for business.
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.
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
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 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.
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.
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.
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.
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"
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.
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).
Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle.
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.
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.
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
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.
Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.
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.
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.
The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.
"How do I look up a value in list ONE and pick up a related value from list TWO"
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
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.
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.
We must be aware of the compliance risks that are relevant with digital assets, specifically, cryptocurrencies.
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.
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
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.
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.
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.
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.
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.
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.
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.
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
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?"
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.
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
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.
"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.
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Financial organization extend credit to borrowers when the borrowers show the ability to repay the loans extended.
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.
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.
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.
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.
Advancements in technology have forced organizations to rethink business models.
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.
This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank.
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Assessment of the cause for a non-compliance is a structured series of branching questions.
Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
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.
Global cash flow is critical to analyzing and underwriting commercial borrowers, especially smaller, privately held firms where the owners and the company are so closely bound together that their assets, liabilities, and income are comingled.
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.
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
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.
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.
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).
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.
This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s.
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
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).
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.
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.
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
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.
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.
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
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.
Microsoft Excel has become the de facto spreadsheet application for business.
This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.
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Category: All
Speaker: All
Month: Any