How to Design and Implement Outstanding KPI Performance Dash
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.
Developing an Environmental Monitoring Program Satisfying FDA's Listeria Monocytogenes
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
2 Hours Virtual Seminar on An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use
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
The U.S. Food and Drug Administration's Regulation of Pet Food: Complying with FDA's Rules for the Marketing and Sale of Dog and Cat Food
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
6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices
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
6-Hour Virtual Seminar on Purchasing and Supplier Controls
This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management enabling you to provide safe and effective products to your customers.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation
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
4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
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
6-Hour Virtual Seminar on Audit like the FDA
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) - An Introduction
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
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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
3-Hour Virtual Seminar: SOP Writing, Training and Compliance in the Pharmaceutical Industry
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
Project Management for Non-Project Managers - Project Management in the Biomedical Industry
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
Project Management for Non-Project Managers
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
Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings
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
FDA Audit Best Practices - Do's and Don'ts
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
Preventing Human Error in the Life Sciences
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
Training Effectiveness: How to Develop Instruments to Measure Learning and Reduce Errors
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
How to Write SOP's for Human Error Reduction
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
Supervising a Human Error Free Environment: You can do a Lot More than you Think
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
How to Write SOP's that Avoid Human Error
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
6-Hour Virtual Seminar on GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
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
4-Hour Virtual Seminar on Combination Product Device Supplier Management Training
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
6-Hour Virtual Seminar on Inspection and Audit Readiness Training for Medical Device Manufacturers
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
4-Hour Virtual Seminar on Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366
This Seminar will provide valuable guidance to regulated companies in development and implementation of Use Engineering / Human Factors Engineering using the 9 stage model in IEC 62366-1.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
4-Hour Virtual Seminar on Managing Risks in Combination Products and Drug Delivery Systems
This seminar will provide valuable guidance to regulated companies in the development and implementation of Product Risk Management Planning, Implementation, and Use.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
4-Hour Virtual Seminar on Cybersecurity and US FDA Requirements
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
Death By CAPA - Does your CAPA Program Need a CAPA?
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
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
Secrets to Writing Effective SOPs for Medical Device QMS
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
Essentials of Validation - IQ OQ PQ
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 Most Common Problems in FDA Software Validation & Verification
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
Device Changes, FDA Changes, and the 510(k)
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
Project Management for FDA-Regulated Companies
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
Failure Investigation and Root Cause Analysis
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
Human Factors/ Usability Studies following ISO62366, the FDA Guidance and the new FDA Draft Guidance
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
Medical Device Software Validation Meeting FDA Regulations
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
How to Prepare for and host an FDA Inspection and respond to 483's
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
How to Deal With Bad Results Under GLP
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
HPLC Analytical Method Development and Validation
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
Analytical Method Validation Under Good Laboratory Practices - GLPs
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 Transfer of Validated Methods
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
Validation of HPLC/UPLC Methodologies
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
3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Excel Basics - Data Visualization - Creating Effective Charts
"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
Excel - Creating an Interactive Dashboard
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
Excel - Power Query for the Everyday Excel User - Part 1
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel - 10 Must-Know Functions to Boost Your Productivity
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
2-Day Virtual Seminar on Computer System Validation for Cloud and COTS Applications
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: 2 Days | Price: $1,045.00 | View Details
2-Day Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA
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
2-Day Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
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. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.
Speaker: Michael Esposito | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot
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
4-Hour Virtual Seminar on Bootcamp on Excel
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel PowerPivot and Power Query
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
Excel Pivot Tables, Pivot Charts, Slicers, and Timelines
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
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
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
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
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards
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
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
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
Excel Charts and Graphs
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 Data Management Tools
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 Lookup Functions
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
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
Packaging and Labeling in the Pharmaceutical Supply Chain
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.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
3-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
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) - An Introduction
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
Artificial Intelligence and Human Error
In today's rapidly advancing technological landscape, AI is transforming the way we live and work. However, while AI has the potential to greatly enhance our lives, it is not without its risks. One of the most significant of these risks is the potential for human error in the development and implementation of AI systems.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
How to Write SOP's for Human Error Reduction
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
How to Write SOP's that Avoid Human Error
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
Writing Excellent SOPs
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
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
Device Changes, FDA Changes, and the 510(k)
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
Excel - Mastering Lookup Functions
"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
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico
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
Medical Device Software Validation Meeting FDA Regulations
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
Medical Device Hazard analysis following ISO 14971
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings
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
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
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
3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
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
Excel - Formulas and Functions 101
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
Excel Basics - Data Visualization - Creating Effective Charts
"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
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel Formulas and Functions
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
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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 Pivot Tables, Pivot Charts, Slicers, and Timelines
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel PowerPivot and Power Query
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
4-Hour Virtual Seminar on Bootcamp on Excel
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
Excel Pivot Tables, Pivot Charts, Slicers, and Timelines
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Project Management for Non-Project Managers - Project Management as applied to Clinical Trials
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 for Non-Project Managers - Role of Project Management in Quality Planning throughout the Medical Device Project Lifecycle
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
Project Management for Non-Project Managers - The Project Management process in the development of In Vitro Diagnostics
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
Project Management for Non-Project Managers - Project Management in Drug Development
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
Excel - Mastering Lookup Functions
"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
6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
How to Write SOP's for Human Error Reduction
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 Studies following ISO62366, the FDA Guidance and the new FDA Draft Guidance
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico
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
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
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
Death by CAPA - Does your Company have the Symptoms?
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
Essentials of Validation - IQ OQ PQ
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
Writing Excellent SOPs
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
Excel - Quick Tips to Help You be More Productive
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
Excel - Mastering Lookup Functions
"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 - Creating an Interactive Dashboard
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
Excel - Power Query for the Everyday Excel User - Part 1
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel - 10 Must-Know Functions to Boost Your Productivity
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
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
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
4-Hour Virtual Seminar on Credit Risk Management- Principles and Practices, Tools and Techniques
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.
Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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 Effectiveness: How to Develop Instruments to Measure Learning and Reduce Errors
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
Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project
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
FDA Audit Best Practices - Do's and Don'ts
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
Project Management for FDA-Regulated Companies
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
Failure Investigation and Root Cause Analysis
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
Project Management for Non-Project Managers - Scheduling your Project
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
Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings
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
3-Hour Virtual Seminar: SOP Writing, Training and Compliance in the Pharmaceutical Industry
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
Writing Excellent SOPs
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
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
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
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
Responsibility for Off-Label Claims in Social Media
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
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
Excel - Formulas and Functions 101
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
Excel Basics - Data Visualization - Creating Effective Charts
"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
How to Write SOP's that Avoid Human Error
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 Reduction Techniques for Floor Supervisors
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
The Transfer of Validated Methods
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
Medical Device Software Validation Meeting FDA Regulations
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
How to Prepare for and Host an FDA Inspection and Respond to 483's
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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 Studies following ISO62366 and the new FDA Guidance
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
Excel PowerPivot and Power Query
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
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
How to Write SOP's that Avoid Human Error
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
Supervising a Human Error Free Environment: You can do a Lot More than you Think
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
Excel - Creating an Interactive Dashboard
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
The U.S. Food and Drug Administration's Regulation of Pet Food: Complying with FDA's Rules for the Marketing and Sale of Dog and Cat Food
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
Excel Pivot Tables, Pivot Charts, Slicers, and Timelines
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
4-Hour Virtual Seminar on Bootcamp on Excel
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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 Challenges for Bioassays
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
Implementing Process Controls for Cell-Based Assays
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel Formulas and Functions
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
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
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) - An Introduction
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
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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
Making your Excel Spreadsheet much Easier to use with Tables
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
Mastering Data And Information Management Essentials
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
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
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
4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot
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
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
Part 2- How to Write More Effective Emails - Improving Your E-Communication Skills
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
Part 1- How to Write Right for Better Business Communication
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
C for Yourself: The 5 C’s of Credit
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
FDA Audit Best Practices - Do's and Don'ts
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
Preventing Human Error in the Life Sciences
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
Project Management for Non-Project Managers
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
Project Management for Non-Project Managers - Scheduling your Project
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
Project Management for Non-Project Managers - Determining the Work that needs to be done
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
Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project
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
Reconciling/Adapting the 8D Problem Solving Process with ISO regulations and 21CFR 820
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
Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation
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
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
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
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
4-Hour Virtual Seminar on Project Management for Non-Project Managers
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
4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation
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
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
4-Hour Virtual Seminar on Bootcamp on Excel
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
Excel - Quick Tips to Help You be More Productive
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
Excel - Mastering Lookup Functions
"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 DetailsExcel - Creating an Interactive Dashboard
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.
View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel - Power Query for the Everyday Excel User - Part 1
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel - 10 Must-Know Functions to Boost Your Productivity
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
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
Excel - Formulas and Functions 101
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
Excel Basics - Data Visualization - Creating Effective Charts
"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
How to Write SOP's that Avoid Human Error
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
How to Write SOP's for Human Error Reduction
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 Reduction Techniques for Floor Supervisors
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
The Human Error Tool Box: A Practical Approach to Human Error
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
21 CFR Part 11 Conformance for Medical Devices
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 Studies following ISO62366 , the FDA Guidance and the new FDA Draft Guidance
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
Medical Device Cybersecurity following latest FDA Guidance
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
How to Prepare for and host an FDA Inspection and respond to 483's
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
Death By CAPA - Does your CAPA Program Need a CAPA?
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
Secrets to Writing Effective SOPs for Medical Device QMS
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
Death by CAPA - Does your Company have the Symptoms?
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
Essentials of Validation - IQ OQ PQ
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
Writing Excellent SOPs
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
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
Is it Microbiological Method Verification or Validation, or Just Semantics?
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
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico
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
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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 Most Common Problems in FDA Software Verification and Validation
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
Device Changes, FDA Changes, and the 510(k)
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
Formulas Automatic Calculation and Key Functions in Excel
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
Excel - Mastering Lookup Functions
"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
Validation of HPLC/UPLC Methodologies
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
The Transfer of Validated Methods
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
Excel Pivot Tables , Pivot Charts, Slicers, and Timelines
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
How to Write SOP's that Avoid Human Error
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
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
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 Formulas and Functions
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 Pivot Tables , Pivot Charts, Slicers, and Timelines
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project
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
3-Hour Virtual Seminar on Bioanalytical Method Validation
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 Challenges for Bioassays
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
Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation
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
Medical Device Cybersecurity and FDA Compliance
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Writing Excellent SOPs
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
Essentials of Validation - IQ OQ PQ
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
Death By CAPA - Does your CAPA Program Need a CAPA?
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
The Human Error Tool box: A Practical Approach to Human Error
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
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
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 Formulas and Functions
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
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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 - Creating an Interactive Dashboard
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
Excel - Quick Tips to Help You be More Productive
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
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
Excel - Formulas and Functions 101
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
Excel Basics - Data Visualization - Creating Effective Charts
"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
Medical Device Hazard analysis following ISO 14971
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
Analytical Method Validation Under Good Laboratory Practices - GLPs
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
Mastering Data and Information Management Essentials
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
Using Excel PivotTables to Easily Summarize and Analyze Data
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
Pivot Table Essentials for Data Analytics in Excel
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
Excel Pivot Tables, Pivot Charts, Slicers, and Timelines
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
Excel PowerPivot and Power Query
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
6-Hour Virtual Seminar on Bootcamp on Excel
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
4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
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
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
Establishing an Effective & Pragmatic Vendor Qualification Program for cGMP Compliance in the Pharmaceutical Industry
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
GMP Environmental Monitoring in Pharmaceutical Clean Rooms
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
CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for Contract Drug Manufacture
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
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
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
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards
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
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
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
4-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
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
4-Hour Virtual Seminar on Project Management for Non-Project Managers
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
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
Excel - Formulas and Functions 101
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
Excel Basics - Data Visualization - Creating Effective Charts
"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
Project Management for Non-Project Managers - Scheduling your Project
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
Project Management for Non-Project Managers - Determining the Work that needs to be done
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
Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project
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
How to Write SOP's for Human Error Reduction
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
Controlling Human Error in the Manufacturing Floor
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
Supervising a Human Error Free Environment: You can do a Lot More than you Think
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
The Human Error Tool Box: A Practical Approach to Human Error
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
European Union Device Regulation (EU MDR)
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
Medical Device Hazard analysis following ISO 14971
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
Medical Device Software Validation Meeting FDA Regulations
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
How to Prepare for and host an FDA Inspection and respond to 483's
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
Validation of HPLC/UPLC Methodologies
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
HPLC Analytical Method Development and Validation
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
The Transfer of Validated Methods
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
Writing Excellent SOPs
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
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
Excel Pivot Tables , Pivot Charts, Slicers, and Timelines
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
Excel PowerPivot and Power Query
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
4-Hour Virtual Seminar on Bootcamp on Excel
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Value Stream Mapping
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
How to Write SOP's that Avoid Human Error
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
Writing Excellent SOPs
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
3-Hour Virtual Seminar on Mastering Excel Pivot Tables
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
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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 Formulas and Functions
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
Human Error Reduction Techniques for Floor Supervisors
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
Controlling Human Error in the Manufacturing Floor
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
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
FDA Audit Best Practices - Do's and Don'ts
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
Project Management for Non-Project Managers - Scheduling your Project
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
Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project
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
Project Management for Non-Project Managers - Determining the Work that needs to be done
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel Pivot Tables, Pivot Charts, Slicers, and Timelines
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 Studies following ISO62366 and the new FDA Guidance
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
Excel - Quick Tips to Help You be More Productive
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
Excel - Mastering Lookup Functions
"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 - Creating an Interactive Dashboard
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
How to Deal With Bad Results Under GLP
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
Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Risk and FDA Inspections: Anticipation, Preparation, Reaction and Conclusion
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
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)
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
Cash Flow Analysis Of Borrower's Repayment Ability
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
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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 Formulas and Functions
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
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
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 - 10 Must-Know Functions to Boost Your Productivity
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) - An Introduction
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
Human Error Reduction Techniques for Floor Supervisors
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
How to write SOP's that Avoid Human Error
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel PowerPivot and Power Query
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings
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
Project Management for Non-Project Managers - Determining the Work that needs to be done
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
Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project
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
Project Management for Non-Project Managers - Scheduling your Project
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
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
Excel - Formulas and Functions 101
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
Excel Basics - Data Visualization - Creating Effective Charts
"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
Analytical Method Validation Under Good Laboratory Practices - GLPs
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
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico
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
Water System Biofilm Control and Microbial Monitoring Myths
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
Writing Excellent SOPs
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
Death By CAPA - Does your CAPA Program Need a CAPA?
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
Essentials of Validation - IQ OQ PQ
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
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
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
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
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
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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
Device Changes, FDA Changes, and the 510(k)
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
The Transfer Of Validated Methods
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
Supervising a Human Error Free Environment: You can do a Lot More than you Think
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
The Human Error Tool Box: A Practical Approach to Human Error
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
FDA Issues Final Rule on Symbols in Labeling
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
Project Management for Non-Project Managers
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
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
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
Responsibility for Off-label Claims in Social Media
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
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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
3-Hour Virtual Seminar on Mastering Excel Pivot Tables
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
4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
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
4-Hour Virtual Seminar on Project Management for Non-Project Managers
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
4-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
Part 1- How to Write Right for Better Business Communication
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
Excel Pivot Tables , Pivot Charts, Slicers, and Timelines
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
4-Hour Virtual Seminar on Bootcamp on Excel
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel PowerPivot and Power Query
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
6-Hour Virtual Seminar on Audit like the FDA
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
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
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
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
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
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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
Supervising a Human Error Free Environment: You can do a Lot More than you Think
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
How to write SOP's for Human Error Reduction
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 Reduction Techniques for Floor Supervisors
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
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
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
Death by CAPA - Does your Company have the Symptoms?
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
Writing Excellent SOPs
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
Responsibility for Off-label Claims in Social Media
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 Regulation of Artificial Intelligence/ Machine Learning
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
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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) - An Introduction
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
Analytical Method Validation Under Good Laboratory Practices - GLPs
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
Device Changes, FDA Changes, and the 510(k)
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
The Most Common Problems in FDA Software Validation & Verification
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
Root Cause Analysis - Starting at the Beginning
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel Pivot Tables , Pivot Charts, Slicers, and Timelines
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
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
Excel - Formulas and Functions 101
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
Excel - 10 Must-Know Functions to Boost Your Productivity
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Use Microsoft Outlook to Its Fullest Extent: Tips, Techniques and Best Practices. It’s Money in Your Pocket!
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
Unmanageable Inbox? Imagine a Clean Inbox and Take Control Today!
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
Learn to Sort, Prioritize and Get Work done Right in your Inbox (Outlook 2013, 2016 & 2019)
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
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
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
Water System Biofilm Control and Microbial Monitoring Myths
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
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
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 Formulas and Functions
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
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
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: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Excel PowerPivot and Power Query
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel Pivot Tables, Pivot Charts, Slicers, and Timelines
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
Excel - Formulas and Functions 101
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
Excel Basics - Data Visualization - Creating Effective Charts
"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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
Essentials of Validation - IQ, OQ, PQ
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
3-Hour Virtual Seminar on Design Controls for Medical Devices
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
Secrets to Writing Effective SOPs for Medical Device QMS
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
Controlling Human Error in the Manufacturing Floor
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
The Human Error Tool Box: A Practical Approach to Human Error
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
How to write SOP's that Avoid Human Error
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 Reduction Techniques for Floor Supervisors
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
Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings
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
Project Management for Non-Project Managers - Determining the Work that needs to be done
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
Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project
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
Project Management for Non-Project Managers - Scheduling your Project
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
4-Hour Virtual Seminar on Bootcamp on Excel
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
4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
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
4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
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
4-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
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
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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
4-Hour Virtual Seminar on Project Management for Non-Project Managers
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
4-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
4-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices
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 Studies following ISO62366 and the new FDA Guidance
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
Medical Device Software Validation Meeting FDA Regulations
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
Writing Excellent SOPs
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
Essentials of Validation - IQ OQ PQ
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 Transfer Of Validated Methods
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
HPLC Analytical Method Development and Validation
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Excel - 10 Must-Know Functions to Boost Your Productivity
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
Excel - Formulas and Functions 101
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
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel Pivot Tables , Pivot Charts, Slicers, and Timelines
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
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
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
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
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
3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification
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
ISO13485: 2016 - Quality Management Systems for Medical Devices
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
Cost of Quality from Theory to Implementation
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
4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
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
4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
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
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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
6-Hour Virtual Seminar on Biostatistics for the Non-Statistician
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
4-Hour Virtual Seminar on Mastering Excel Pivot Tables
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
4-Hour Virtual Seminar on Project Management for Non-Project Managers
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
4-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
4-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
3-Hour Virtual Seminar on Bioanalytical Method Validation
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 Challenges for Bioassays
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
Implementing Process Controls for Cell-Based Assays
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
FDA Audit Best Practices - Do's and Don'ts
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
Preventing Human Error in the Life Sciences
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
Device Changes, FDA Changes, and the 510(k)
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
The Most Common Problems in FDA Software Validation & Verification
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
Root Cause Analysis - Starting at the Beginning
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
How to Prepare for and Host an FDA Inspection and respond to 483's
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
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
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 Formulas and Functions
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
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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
4-Hour Virtual Seminar on Bootcamp on Excel
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
4-Hour Virtual Seminar on Project Management for Non-Project Managers
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
4-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
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
6-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
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
6-Hour Virtual Seminar on Statistics for Process Control
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
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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
Essentials of Validation - IQ OQ PQ
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
Writing Excellent SOPs
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 Regulation of Artificial Intelligence/ Machine Learning
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
The Human Error Tool Box: A Practical Approach to Human Error
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
Controlling Human Error in the Manufacturing Floor
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
Excel - 10 Must-Know Functions to Boost Your Productivity
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
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
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
Excel - Formulas and Functions 101
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
Excel PowerPivot and Power Query
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
C for Yourself: The 5 C's of Credit
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
4-Hour Virtual Seminar on How to Write Better Communications and Emails
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
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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) - An Introduction
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
Responsibility for Off-label Claims in Social Media
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Medical Device Cybersecurity and FDA Compliance
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
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
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
Analytical Method Validation Under Good Laboratory Practices - GLPs
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
HPLC Analytical Method Development and Validation
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
Validation of HPLC/UPLC Methodologies
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
3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification
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
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
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
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
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
Water System Biofilm Control and Microbial Monitoring Myths
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
Excel Pivot Tables , Pivot Charts, Slicers, and Timelines
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
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
3-Hour Virtual Seminar on Design Controls for Medical Devices
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
Excel Data Visualization - Charts and Infographics
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Excel - Formulas and Functions 101
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
Medical Device Hazard analysis following ISO 14971
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
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
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 New Import Program for 2022 and Impact of the COVID-19
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
Responsibility for Off-label Claims in Social Media
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
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Time-Saving Excel Tips, Tricks and 100 Shortcuts
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
4-Hour Virtual Seminar on Death by CAPA - Does your CAPA Program need a CAPA?
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
4-Hour Virtual Seminar on Project Management for Non-Project Managers
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
Project Management for Non-Project Managers - Scheduling your Project
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
Project Management for Non-Project Managers - How to effectively monitor and control your project
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
Project Management for Non-Project Managers - Forming, developing, and managing your project team
The subject of this webinar is building the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Project Management for Non-Project Managers - Determining the work that needs to be done
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
Project Management for Non-Project Managers - How to communicate project actions and progress - conducting effective project review meetings
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
FDA Inspections - Do's and Don'ts
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
How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
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
2-Hour Virtual Seminar on Microsoft Outlook on Steroids
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 Formulas and Functions
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
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices
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
6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
6-Hour Virtual Seminar on Biostatistics for the Non-Statistician
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
Writing Excellent SOPs
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
Death By CAPA - Does your CAPA Program Need a CAPA?
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
The Most Common Problems in FDA Software Validation & Verification
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
ISO-IEC 17025:2017 Update Introduction: Everything Old is New Again
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
Responsibility for Off-label Claims in Social Media
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
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
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
How to Prepare for and Host an FDA Inspection and respond to 483's
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
European Union Device Regulation (EU MDR)
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
Medical Device Hazard analysis following ISO 14971
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 Regulation of Artificial Intelligence/ Machine Learning
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
Medical Device Complaints & CAPA
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
Medical Device Software Cybersecurity and IEC 62304 Compliance
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
Medical Device Cybersecurity and FDA Compliance
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
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
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
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
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
The Human Error Tool Box: A Practical Approach to Human Error
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
How to write SOP's that Avoid Human Error
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
Controlling Human Error in the Manufacturing Floor
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
How to write SOP's for Human Error Reduction
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) - An Introduction
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
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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
Device Changes, FDA Changes, and the 510(k)
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
HPLC Analytical Method Development and Validation
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
The Transfer Of Validated Methods
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
Analytical Method Validation Under Good Laboratory Practices - GLPs
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 HPLC/UPLC Methodologies
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
Water System Biofilm Control and Microbial Monitoring Myths
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
3-Hour Virtual Seminar on Project Management for Non-Project Managers
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
Project Management for Non-Project Managers
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
European Union Device Regulation (EU MDR)
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
Essentials of Validation - IQ OQ PQ
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
Project Management for Non-Project Managers
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
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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
Excel PowerPivot and Power Query
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Root Cause Analysis - Starting at the Beginning
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 Most Common Problems in FDA Software Validation & Verification
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's New Import Program for 2022 and Impact of the COVID-19
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 Human Error Tool Box: A Practical Approach to Human Error
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
How to Write SOP's for Human Error Reduction
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
3-Hour Virtual Seminar on Bioanalytical Method Validation
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
Auditing Laboratories Conducting Assays Supporting Biologics
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
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
6-Hour Virtual Seminar - Batch Record Review and Product Release
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
FDA Audit Best Practices - Do's and Don'ts
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
Mandating COVID Vaccines at Work
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
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
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 Formulas and Functions
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 PowerPivot and Power Query
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
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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
Writing Excellent SOPs
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
Death By CAPA - Does your CAPA Program Need a CAPA?
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
3-Hour Virtual Seminar on Design Controls for Medical Devices
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
Essentials of Validation - IQ OQ PQ
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
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
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
Device Changes, FDA Changes, and the 510(k)
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 Inspections - Do's and Don'ts
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
Project Management for Non-Project Managers
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
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
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
Responsibility for Off-label Claims in Social Media
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Mandating COVID Vaccines at Work
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
Medical Device Complaints & CAPA
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
European Union Device Regulation (EU MDR)
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
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
Water System Biofilm Control and Microbial Monitoring Myths
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
Secrets to Writing Effective SOPs for Medical Device QMS
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
Essentials of Validation - IQ, OQ, PQ
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
Writing Excellent SOPs
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
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
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
How to Write SOP's for Human Error Reduction
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
Controlling Human Error in the Manufacturing Floor
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
Project Management for Non-Project Managers
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
Responsibility for Off-label Claims in Social Media
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
6-Hour Virtual Seminar on Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices
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
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
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
Water System Biofilm Control and Microbial Monitoring Myths
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 to Write SOP's for Human Error Reduction
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 Formulas and Functions
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
6-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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
4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) Comparing and Contrasting GMP
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
6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
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
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mandating COVID Vaccines at Work
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
6-Hour Virtual Seminar on Controlling Human Error in the Manufacturing Floor
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
Using Statistics to Determine Sample Size
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
Sample Size Determination for Design Validation Activities
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
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
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
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
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
FDA Inspections - Do's and Don'ts
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
Project Management for Non-Project Managers
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
Secrets to Writing Effective SOPs for Medical Device QMS
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
Death By CAPA - Does your CAPA Program Need a CAPA?
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
3-Hour Virtual Seminar on Design Controls for Medical Devices
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
Essentials of Validation - IQ, OQ, PQ
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
Medical Device Software Cybersecurity and IEC 62304 Compliance
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Project Management for FDA-Regulated Companies
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
Device Changes, FDA Changes, and the 510(k)
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
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
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 Most Common Problems in FDA Software Validation & Verification
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
The Human Error Tool Box: A Practical Approach to Human Error
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
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
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 Challenges for Bioassays
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
Water System Biofilm Control and Microbial Monitoring Myths
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
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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
3-Hour Virtual Seminar: SOP Writing, Training and Compliance in the Pharmaceutical Industry
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
Computer System Validation (CSV) for FDA-Regulated Computers
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
Mandating COVID Vaccines at Work
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
6-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Cost of Quality from Theory to Implementation
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
ISO13485: 2016 - Quality Management Systems for Medical Devices
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
Analytical Method Validation Under Good Laboratory Practices - GLPs
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
Writing Excellent SOPs
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
The Human Error Tool Box: A Practical Approach to Human Error
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
Root Cause Analysis - Starting at the Beginning
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
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
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
Responsibility for Off-label Claims in Social Media
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
Project Management for Non-Project Managers
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 Regulation of Artificial Intelligence/ Machine Learning
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)
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 for FDA-Regulated Companies
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
How to write SOP's for Human Error Reduction
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
Essentials of Validation - IQ, OQ, PQ
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
Secrets to Writing Effective SOPs for Medical Device QMS
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
Death By CAPA - Does your CAPA Program Need a CAPA?
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
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
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
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
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
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
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
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
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 Transfer Of Validated Methods
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
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices)
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
Computer System Validation (CSV) for FDA-Regulated Computers
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
Preventing Human Error in the Life Sciences
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
INCOTERMS 2020 Made Easy - Decoding your Shipment
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 Challenges for Bioassays
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
HPLC Analytical Method Development and Validation
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
The Transfer Of Validated Methods
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
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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) - An Introduction
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
How to write SOP's that Avoid Human Error
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
Water System Biofilm Control and Microbial Monitoring Myths
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
Cost of Quality from Theory to Implementation
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
ISO13485: 2016 - Quality Management Systems for Medical Devices
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
Responsibility for Off-label Claims in Social Media
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
6-Hour Virtual Seminar on Statistics for Process Control
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
FDA's New Import Program for 2020 and Impact of the COVID-19
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
Responsibility for Off-label Claims in Social Media
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 Human Error Tool Box: A Practical Approach to Human Error
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
Medical Device Hazard analysis following ISO 14971
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
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
FDA Regulation of Artificial Intelligence/ Machine Learning
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
6-Hour Virtual Seminar on Statistical Process Control & Process Capability
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
6-Hour Virtual Seminar on Biostatistics for the Non-Statistician
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
6-Hour Virtual Seminar on Bootcamp on Excel
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
Combating Racism in the Workplace
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
3-Hour Virtual Seminar on Bioanalytical Method Validation
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
HPLC Analytical Method Development and Validation
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
Secrets to Writing Effective SOPs for Medical Device QMS
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
How to Prepare for and Host an FDA Inspection and respond to 483's
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
Surviving OSHA Audit in Six Easy Steps
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
How to write SOP's for Human Error Reduction
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
6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
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
Water System Biofilm Control and Microbial Monitoring Myths
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
3-Hour Virtual Seminar on Design Controls for Medical Devices
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
Essentials of Validation - IQ, OQ, PQ
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
Writing Excellent SOPs
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
The Most Common Problems in FDA Software Validation & Verification
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
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
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
Device Changes, FDA Changes, and the 510(k)
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
Project Management for FDA-Regulated Companies
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
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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
Root Cause Analysis - Starting at the Beginning
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
Analytical Method Validation Under Good Laboratory Practices - GLPs
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 Transfer Of Validated Methods
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
Validation of HPLC/UPLC Methodologies
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
How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
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 Inspections - Do's and Don'ts
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
How to write SOP's that Avoid Human Error
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
FDA Regulation of Artificial Intelligence/ Machine Learning
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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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
Responsibility for Off-label Claims in Social Media
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
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
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
3-Hour Virtual Seminar on Project Management for Non-Project Managers
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
Mandating COVID Vaccines at Work
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
Medical Device Software Cybersecurity and IEC 62304 Compliance
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
6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada
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
4-Hour Virtual Seminar - Batch Record Review and Product Release
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
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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
6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices
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
Risk Management - Implementing ISO14971: 2019
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
6-Hour Virtual Seminar on bootcamp on Excel
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
6-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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
2-Day Virtual Seminar on Best Practices for Import & Export Control & Customs Compliance During & After COVID 19
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
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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
6-Hour Virtual Seminar on Project Management for Non-Project Managers
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
6-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
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
6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
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
6-Hour Virtual Seminar - Batch Record Review and Product Release
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
6-Hour Virtual Seminar on EU Regulatory Affairs strategy during development of medicinal products
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
6-Hour Virtual Seminar on Biostatistics for the Non-Statistician
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
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
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
Mandating COVID Vaccines at Work
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
Auditing Laboratories Conducting Assays Supporting Biologics
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
How to write SOP's for Human Error Reduction
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
Is it Microbiological Method Verification or Validation, or Just Semantics?
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
CAPA: Corrective and Preventative Actions and Non-Conformances
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
How Will FDA's New Approach to CSV Make Implementations Easier?
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
European Union Device Regulation (EU MDR)
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
Medical Device Complaints & CAPA
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