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: 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
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