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: Aug. 2, 2022
Description: This webinar shows you how to incorporate cybersecurity into your quality system and defend it to interested third parties. You’ll stay compliant, bolster your device defenses and protect patients, not to mention stay out of security breach-related headlines. You’ll learn:
- How cybersecurity relates to design controls and the quality system more generally;
- Key tips for defending cybersecurity during an FDA inspection or notified body audit, even when the investigator or auditor is not familiar with cybersecurity concepts; and
- How addressing cybersecurity risk relates to product risk management.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eric Henry, Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences Practice, King & Spalding
Recorded on: July 28, 2022
Description: James Pink, senior director, medical at Element Materials Technology, shares how you can stay on top of the EU-MDR requirements through a carefully designed strategy for regulatory compliance. He’ll explain:
- The regulatory framework around the EU-MDR, including common specifications, guidances, harmonized standards and interacting EU laws;
- How to develop an effective and value-added strategy for regulatory compliance, including developing tools and systems to track regulatory updates, setting equivalence requirements and managing changes to standards and medical state-of-the-art good practices; and
- How to plug into those aspects of EU regulations you may not have known exist but are essential, including the forthcoming Artificial Intelligence Act, cybersecurity frameworks, data protection law and hazardous substance requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Pink, Senior Director, Medical, Element Materials Technology
Recorded on: July 27, 2022
Description: Ellen Weiss, PCM Trials’ vice president of in-home solutions and decentralized clinical trials (DCT), explains the positive effects hybrid and DCT methods have on clinical trials now and into the future, helping you fully realize the advantages for your trials, sharing:
- Clinical trial-related lessons learned from the COVID-19 pandemic;
- The most-requested and most-used activities in home visit programs today; and
- How to realize the benefits of decentralized clinical trials going forward.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ellen Weiss, Vice President of In-home Solutions and Decentralized Clinical Trials, PCM Trials
Recorded on: July 13, 2022
Description: Communications compliance expert Mark Senak walks you through what you must know and do to avoid OPDP enforcement action, sharing the latest trends and FDA research so you can understand the most frequent mistakes and avoid the greatest risks. He discusses:
- The most common ad and promo violations that trigger regulatory action by the FDA;
- The most recent trends with respect to enforcement and different types of promotional communications, especially in response to direct-to-consumer (DTC) promotions; and
- How digital and social promotional communications have impacted enforcement, including via Twitter and Facebook.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mark Senak, Senior Vice President and Partner, FleishmanHillard
Recorded on: June 28, 2022
Description: A team of quality management and technology solutions experts explains how a predictive system can identify and mitigate compliance risks and ensure uniform quality and compliance across every level and site within your organization. They’ll share how to:
- Effortlessly monitor the regulatory landscape, correct issues found in your corrective and preventive action (CAPA) and audit programs, and avoid negative consequences with a predictive compliance solution;
- Easily conduct proactive quantitative analysis that furthers your data literacy and minimizes uncertainty with built-in data-driven compliance — in the form of a quantitative score — to take the guesswork from your regulatory project planning and compliance activities; and
- Save time and money when you eliminate unnecessary monitoring and reviewing of public data sources.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kamal Biswas, President and COO, Xybion; Heidi Krueger, Director of Quality Assurance, Xybion; Bob Friedman, Chief Technology Officer, Xybion; Joe Kalina, Director of Marketing, Xybion
Recorded on: June 23, 2022
Description: Regulatory affairs experts Richard Kingston and D iane McEnroe discuss being prepared for running an efficient and smooth product recall. They’ll cover:
- The key components of the FDA guidance Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, including identifying and training appropriate personnel and developing a recall action plan;
- Determining potential reporting obligations associated with affected products, recordkeeping and other legal obligations; and
- Evaluating exiting SOPs or recall plans to ensure that you are up to date with your recall approach, including enhanced training.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Richard Kingston, Co-Founder and President of Regulatory and Scientific Affairs, and Senior Clinical Toxicologist, SafetyCall International; Diane McEnroe, Partner, Sidley Austin’s Food, Drug and Medical Device Regulatory Practice
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