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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Webinar Training Pass
Recorded on: June 22, 2017
Description: Quality systems expert Dan O’Leary unravels a tangle of FDA rules and international standards that govern design control. He covers:
- Design control from the risk management perspective and vice versa;
- Recognizing when requirements of the one system support/complement requirements of the other; and
- Using product safety standards to improve design control and risk management efficiency.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: June 13, 2017
Description: Experts Alex Brill and Nancy Bradish Myers share insights and predictions about the current user fee reauthorization process. They discuss:
- How the FDA affects drug competition at every level — brand-to-brand, brand-to-generic, generic-to-generic, biologic-to-biosimilar;
- Expedited approvals and economic incentives — how the FDA promotes drug competition; and
- Five ways Congress and the FDA can boost competition and the likelihood of each.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Alex Brill, CEO, Matrix Global Advisors, and Nancy Bradish Myers, President, Catalyst Healthcare Consulting Inc.
Recorded on: June 8, 2017
Description: Quality advisors Mark Turner and Michelle Boucher discuss current industry trends, including:
- The Case for Quality and how manufacturers can bridge current gaps;
- How manufacturers should respond to rigid FDA or EU regulations and authorities; and
- Novartis’ approach to the Case for Quality and how it applies current trends in practice.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mark Turner, Service Delivery Manager, Engineering, Novartis/Alcon; Michelle Boucher, Vice President for Research, Tech-Clarity
Recorded on: June 7, 2017
Description: Regulatory experts Meaghan Bailey and Caroline Rhim discuss lesser known premarket pathways created by the 21st Century Cures Act. They cover:
- How to sort through the FDA feedback process;
- Where and how to get regulatory information on your product classification;
- How to focus communications with the FDA to direct your products to the best premarket pathways; and
- The game-changers lurking within the 21st Century Cure Act and pending MDUFA goals.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Meaghan Bailey, Executive Director, and Caroline Rhim, Managing Director, Medical Device Consulting, NSF Health Sciences
Recorded on: June 6, 2017
Description: Food law expert Steve Armstrong explains current law and regulation covering every aspect of food process labeling. He discusses:
- Where process labeling fits among labeling claims;
- Opportunities and challenges in transparency;
- How to spot a risky claim;
- How to substantiate claims that are challenged; and
- Best practices for process label transparency.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steve Armstrong, independent advisor for EAS Consulting Group
Recorded on: May 31, 2017
Description: Global drug and device expert Michael Burke explains how the upcoming Brexit separation from the European Union may take shape. He discusses:
- How Brexit may affect drug and device companies’ operations;
- How marketing authorization will be affected in the EU and UK; and
- Possible new locations for European Medicines Agency headquarters.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Michael Burke, Partner, Arnall Golden Gregory
Recorded on: May 30, 2017
Description: Life Sciences experts Carmen Medina and Daniela Jansen discuss steps to take to prepare for the FDA’s quality metrics program. They cover:
- Understanding the FDA’s quality metrics vision;
- Developing enterprise-wide quality metrics for product lifecycle;
- Linking to lifecycle process validation; and
- Alternative Metrics.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Carmen Medina, Vice President, Technical Services, PAREXEL Consulting; and Daniela Jansen, Director, Solution Marketing, Dassault Systèmes BIOVIA
Recorded on: May 23, 2017
Description: Supplier contract specialist Courtney Stevens walks you through the essentials of supply contracts. She covers:
- How to approach a contract negotiation;
- What every contract must include;
- Insurance clauses and certificates of insurance; and
- Audit provisions for further protection.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Courtney Stevens, Senior Attorney-Risk Management and Loss Control, MedMarc Insurance Group
Recorded on: May 18, 2017
Description: Quality systems expert Dan O’Leary explains the requirements of the FDA, EU and ISO for analyzing trends in medical device complaints. He discusses:
- Systems for analyzing, classifying and coding complaints;
- FDA-specific coding for MDRs;
- Coding derived from risk management files; and
- Linking complaints, coding and risk management.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: May 17, 2017
Description: Three former colleagues of new FDA Commissioner Scott Gottleib discuss how his qualifications make him the best choice for the position. They cover:
- How his experience and public statements indicate what his agenda as commissioner may include;
- How he may approach staffing and funding challenges;
- Potential increased predictability in the approval process and more in-depth guidance; and
- A new forward-looking approach to using real-world evidence.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Marc Scheineson, Partner, Alston & Bird LLP; Peter Pitts, Co-founder and President, Center for Medicine in the Public Interest