The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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If you are already a Training Pass member, login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video, click the "Download Presentation" link.
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Webinar Training Pass
Recorded on: Dec. 7, 2023
Description: James Shore — an expert with more than 30 years of quality and supplier management experience — explains how to effectively use a risk assessment approach to determine the “level of intensity” needed in your quality agreements. You’ll learn:
- Understand the regulatory requirements for quality agreements
- Understand how effective quality agreements not only meet requirements, but also provide additional business protection from regulatory enforcement action
- Learn how to use risk assessment methods to determine the “level of intensity” needed in an agreement based on the type of supplier or contractor
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Shore, Chief Quality Officer, Quality Lean Solutions
Recorded on: Nov. 30, 2023
Description: Eric Henry will explain why companies should focus on cybersecurity during facility inspections and device submissions, how the defense of cybersecurity relates to design control, and how risk management relates to cybersecurity threat modeling and vulnerability assessment during inspections. You’ll learn:
- Understand the differences and similarities in global cybersecurity regulatory requirements;
- Gain tips for defending cybersecurity during FDA inspections; and
- Identify and discuss common cybersecurity issues called out during inspections and submission reviews.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eric Henry, Senior Quality Systems and Compliance Advisor, King & Spalding LLC
Recorded on: Nov. 2, 2023
Description: Jay Crowley, vice president of medical devices and solutions at USDM Life Sciences, will explain the role that UDI systems and their associated data play as a foundation for solving emerging global regulatory, commercial, and quasi-regulatory use issues for your company’s medical devices. You’ll learn:
- How UDI systems are emerging globally;
- How UDI systems can be used to support regulatory and commercial purposes;
- The FDA’s expectations for data alignment through UDI systems; and
- The need for alignment and reuse of data across various systems and outputs.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jay Crowley, Vice President, Medical Device Service and Solutions, USDM Life Sciences
Recorded on: Oct. 31, 2023
Description: The term “Quality Culture” has been around for years, but few companies have mastered what it means or how to implement and measure a culture of quality in a GMP-regulated environment. This webinar will help provide attendees with a better understanding of the concepts behind quality culture, as well as provide some strategies for implementation and metrics for measuring performance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Sarah Tanksley, President and CEO, Tanksley Consulting Group Inc.
Recorded on: Oct. 26, 2023
Description: This webinar, presented by a panel of FDA-watchers and regulatory experts, looks at what can we expect the FDA to seek to achieve in the coming year? What priorities will the agency set? What will the 2024 budget enable the FDA to achieve? What will the regulatory and political environment be like? How will companies need to adjust?
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne Pines, APCO Worldwide; Steven Grossman, HPS Group; Cathy Burgess, Alston & Bird; Josh Oyster, Ropes & Gray; and Lowell Zeta, Hogan Lovells
Recorded on: Sept. 28, 2023
Description: Steven Walfish provides real-world examples of the assumptions and risks associated with calculating sample sizes in drug, device and combination product design. You’ll learn how to:
- Develop a clear understanding of how to implement sound statistical methods in verification and validation activities.
- Understand why specific standards, such as ANSI Z1.4, should not be used for validation activities.
- Master game-changing shortcuts that will simplify your sample size calculation efforts and ultimately ensure better outcomes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Walfish, President, Statistical Outsourcing Services
Recorded on: Sept. 28, 2023
Description: True track and trace of individual items throughout the supply chain is necessary and may be more involved than just what is needed from compliance. This webinar helps you understand:
- Why supply chain traceability and product authentication capabilities can be essential to protect the healthcare medical device.
- High-profile use cases and real-world examples of issues that have occurred and the steps taken to solve the problem. Proactively including these techniques can prevent issues from occurring in the first place.
- How to maximize the value of compliance barcodes and leverage them as a strong authentication layer.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Dave DeJean, Vice President Global Strategic Accounts, Systech; and Steve Tallant, Director of Market Development, Systech
Recorded on: Aug. 24, 2023
Description: Covering an overview of a quality risk management system for medical devices, this webinar provides you with the confidence needed to identify, reduce and eliminate failure modes and more:
- Learn the FDA’s specific expectations for risk management;
- Come away with a better understanding of the ISO 14971 risk management process;
- Grasp best practices for deploying risk control and mitigation methodologies; and
- Become familiar with how to use the many different types of FMEAs.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eliot Zaiken CQE, CMDA, CQA, President, Technology Device Enterprises, Medical Device/Combo Product Quality/Regulatory Consultant
Recorded on: Aug. 10, 2023
Description: Peter Knauer, a CMC and RA expert, walks through statistical approaches that have been previously used and accepted by the FDA. This webinar helps you:
- Understand device reliability;
- Learn the current FDA thinking around reliability;
- Discover risk-based approaches to determining reliability, such as FTA; and
- Undertake probabilistic determinations of reliability.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Peter Knauer, Managing Partner, Sage BioPartners
Recorded on: July 19, 2023
Description: Dave Petrich, vice president of quality and regulatory at the Landrich Group, discusses the critical relationship between design control and risk management throughout the entire medical device development process. He’ll provide:
- A better understanding of key definitions for design control and risk management;
- The latest regulations associated with design control and risk management, including 21 CFR 820.30;
- Lessons learned from issues that lead to 483s/warning letters; and
- Best practices for design control and risk management, such as FDA recommendations in Design Control Guidance for Medical Device Manufacturers.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dave Petrich, Vice President of Quality and Regulatory, Landrich Group