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.
BUY NOW Single-User 1-Year Unlimited Access $1,362
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.
Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 to receive a custom quote.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.
Webinar Training Pass
Recorded on: June 22, 2022
Description: Medical device regulatory expert Jessica Ringel explains regulatory process changes ahead at the FDA Center for Devices and Radiologic Health (CDRH). She discusses:
- CDRH’s strategic priorities for the next three years and how the center could translate them into regulatory action;
- How CDRH’s priority for advancing health equity could affect the design of your devices and clinical trials;
- How to increase your chances of regulatory success by understanding the challenges and pressures faced by CDRH staff and improving your interactions with the FDA.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jessica Ringel, Partner, King & Spalding
Recorded on: June 21, 2022
Description: Medical device regulatory expert Pamela Forrest explores the most common reasons devicemakers run afoul of medical device reporting requirements, including:
- Incomplete understanding of the term “serious injury;”
- Improper malfunction analysis; and
- Missed deadlines and inadequate procedures.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Pamela Forrest, Partner, Covington & Burling’s medical devices and diagnostics practice
Recorded on: June 9, 2022
Description: Representatives of quality management solutions company ETQ discuss the benefits of using a single, consistent process to improve investigations of lab discrepancies.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Art Gehring, VP of Marketing, Kim Wakeman, Product Manager, and Eric Dano, Solutions Engineer, ETQ
Recorded on: May 24, 2022
Description: Electronic data management experts discuss how automating data from numerous sources can make it available for consumption by clinical teams for better decisionmaking. They cover:
- The role comprehensive analytics plays in establishing effective oversight;
- How clinical teams will benefit from a centralized clinical data platform that contains both clinical and operational data from numerous sources;
- What types of insights are most important for trial oversight; and
- Case studies illustrating how analytics that power oversight deliver ROI and enhanced collaboration.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jason Gubb, Global Clinical Operations Consultant and Co-founder, EmergentTeams; Sheila Rocchio, Chief Marketing Officer, eClinical Solutions; and Jason Konn, Product Manager, eClinical Solutions
Recorded on: May 24, 2022
Description: Quality management experts Teresa Gorecki and Ken Ray discuss measuring, diagnosing and improving quality culture in your organization. They cover:
- Quality culture as a risk reduction and mitigation strategy;
- Identifying weak systems and structures; and
- Understanding individual and group beliefs within an organization.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Teresa Gorecki, Practice Director, Compliance Architects, and Ken Ray, Co-developer and Practice Lead, Quality Pulse
Recorded on: May 17, 2022
Description: Consultant and former CDER official Radhika Rajagopalan discusses the center’s areas of focus for 2022, including:
- Safety surveillance;
- Quality, effectiveness and safety of generic drugs;
- Misuse of opioid drugs; and
- Data standards.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Radhika Rajagopalan, consultant, EAS Consulting Group
Recorded on: May 17, 2022
Description: Clinical trial data experts Ching Tian and Sherry Volk present three data trends they have seen in developing decentralized trials (DCT). They discuss:
- Increasing data volume and sources;
- Operational data and insights; and
- The need for better data visibility throughout the course of the trial.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Ching Tian, Senior Vice President, Medable; Sherry Volk, Principal Portfolio Lead, eClinical Solutions
Recorded on: May 10, 2022
Description: FDA regulatory expert Kristin Zielinski Duggan digs into the FDA’s guidance around real-world evidence (RWE) and presents key examples of how this evidence has been used for medical device decisions. She discusses:
- The FDA’s framework for the RWE program;
- The FDA’s April 2021 report on examples of RWE used in medical device regulatory decisions; and
- Using RWE for premarket and postmarket obligations.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kristin Zielinski Duggan, Partner, Hogan Lovells
Recorded on: April 28, 2022
Description: Regulatory attorneys Kellie Combs and Josh Oyster discuss the FDA and FTC regulatory frameworks for promotional communications and the enforcement landscape. Topics include:
- FDA requirements and guidances;
- Providing risk-benefit information on social media platforms;
- Third-party social media communications; and
- Endorsements and testimonials.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kellie Combs, Partner, and Josh Oyster, Partner, Ropes & Gray’s Life Sciences Regulatory and Compliance
Recorded on: April 28, 2022
Description: Electronic systems experts Kent Malmros and Carol Benson discuss implementing a technology to create better organizational governance, change management practices and redefine learning. Topics include:
- Training technology categories;
- Document and content management tools; and
- Benefits of managing all training-related process in one place.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kent Malmros, Senior Director of Vault Training, Veeva Systems; and Carol Benson, Associate Director of Quality eSystems, Iacyte