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: March 28, 2024
Description: Learn the potential impact on drug development of the Inflation Reduction Act (IRA) and negotiated prices for some top-selling Medicare Part D drugs. Presentation Takeaways:
- Gain a greater understanding of the “big picture” – examining what the IRA means for the future of drug innovation.
- Understand the IRA legislation’s key provisions.
- Identify the drug development areas that will be most impacted.
- Revise your strategic plans in the face of the IRA’s mandates.
- Prepare your drug development business for enforcement of the IRA.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Ken Getz, Executive Director of the Tufts Center for the Study of Drug Development (CSDD) and a Research Professor in the Tufts University School of Medicine; and Emily Botto, Senior Research Analyst, Tufts CSDD
Recorded on: March 21, 2024
Description: Learn best practices for interacting with the FDA and other global regulators in meetings at the different review stages, and how you can be proactive in planning to ensure a timely review and — if all goes well — approval of your product. In preparation for a product meeting with the FDA, you’ll develop a gameplan that:
- Defines the purpose of the meeting(s)
- Shows the value of preparation and rehearsing before meetings
- Understands the process at every stage of the product journey
- Adheres to timelines to ensure success
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mark Lane, Vice President of Development Consulting and Scientific Affairs, PharmaLex; Patrick Larcier, Senior Director of Strategic Product Development Solutions, PharmaLex; and Anna Perelka, Director of Regulatory Affairs U.S., PharmaLex
Recorded on: March 14, 2024
Description: Eric Henry, senior quality systems and compliance advisor of FDA & Life Sciences Practice at King & Spalding law firm, explains the new requirements for medical device manufacturers in the Quality Management System Regulation (QMSR). Get full details of the FDA’s expectations for the transition from the 27-year old Quality System Regulation to the QMSR, including:
- The drivers leading to the U.S. harmonization of the QMSR with ISO 13485:2016
- How the QMSR incorporates ISO 13485:2016
- How the QMSR differs from ISO 13485:2016
- The FDA’s new inspection scheme replacing the current Quality System Inspection Technique (QSIT)
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eric Henry, Senior Quality Systems and Compliance Advisor of FDA & Life Sciences Practice, King & Spalding
Recorded on: Feb. 29, 2024
Description: Tim Fischer, a quality expert with more than 30 years’ experience in the life science compliance arena, explains how compliance with the ICH Q10 quality management standard can help you to align your quality system to your business model and improve your quality culture. You will:
- Discover the benefits of ICH Q10 and quality system alignment
- Compare the elements of your quality policy with ICH Q10
- Visualize what management responsibilities look like in relation to ICH Q10
- Define the framework for continuous improvement and the process performance lifecycle in line with ICH Q10
- Identify monitoring activities for a quality system based on ICH Q10
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Fischer, Managing Partner of Great Solutions
Recorded on: Jan. 25, 2024
Description: Beth Slater provides a clear understanding of the tools used for risk management in the quality management system and shows how to properly apply them throughout the product lifecycle. You’ll receive:
- Expert insight into the ICH Q9 (R1) Risk Management Guidance changes
- Knowledge of how to integrate Risk Management into QA processes
- Understanding of the tools and methods for implementing and measuring risk management within a QA system
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Beth Slater, President, Quality Confidential
Recorded on: Jan. 23, 2024
Description: If you’re still relying on traditional quality management system (QMS) solutions or contemplating a shift to digital processes, this webinar is your guide to making informed decisions. Primary benefits are:
- Revolutionize Your Processes: Learn how AI-integrated QMS optimizes operations, streamlines communication, and enhances collaboration across departments.
- Proactive Quality Management: Understand how AI enables a shift from reactive to proactive quality management, minimizing risks, and ensuring compliance with regulatory standards.
- In-Depth Insights for Decision-Making: Explore how AI-driven analytics provide actionable insights, empowering your team with strategic information for smarter business decisions.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mickey Landkof, General Manager, Dot Compliance Inc.; and Yuval Nardi, Chief Data Scientist, Dot Compliance Inc
Recorded on: Dec. 13, 2023
Description: Changes and updates to regulatory compliance are inevitable, including how the FDA is managing inspections for medical device manufacturers. You’ll learn:
- The factors that determine mission critical inspections;
- Examples of FDA suggested alternative inspection tools;
- What did the passage of FDORA authorize for medical device inspections; and
- How did the restructuring of ORA aim to meet current challenges.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Judith Meritz, Life Sciences Expert and Consultant, Meritz & Muenz LLP
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