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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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Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
ICH Stability Requirements
66 minutes
Recorded on: July 20, 2017
Description: CMC program design specialist Wayland Rushing interprets stability requirements in ICH Q1 and explains how to tailor a compliance routine to fit your specific products. He discusses:
- The requirements for ICH stability studies;
- The requirements for analytical methods; and
- How to interpret data generated by the stability programs.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Wayland Rushing, Director of Scientific Affairs, EAG Labs
Spreadsheet Validation
88 minutes
Recorded on: July 18, 2017
Description: Computer system validation expert David Harrison discusses best practices and available options for validating spreadsheets. He covers:
- Exactly what the FDA looks for and why;
- Spreadsheet validation "gaps" the FDA is targeting;
- How to generate spreadsheet specifications and qualification protocols; and
- How to test spreadsheets and macros.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Harrison, Principal Consultant, CSV Compliance Limited
FDA’s Big 5 Challenges
83 minutes
Recorded on: July 13, 2017
Description: Life sciences lawyer Roseann Termini discusses the biggest challenges facing the FDA in 2017, including:
- Botox approvals;
- Marijuana regulation;
- The Opioid task force;
- The Intended Use rule; and
- The Right-to-Try movement.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Roseann Termini, Editor, Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements
Recorded on: July 12, 2017
Description: Statistician Steven Walfish outlines the requirements for statistical techniques and sample size and explains how they impact design control processes. He discusses:
- Common sources of errors;
- What types of requirements lend themselves to statistics in verification and validation; and
- Examples of problems in which we apply statistics.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Walfish, President, Statistical Outsourcing Services
Develop a Process Validation Roadmap
67 minutes
Recorded on: June 27, 2017
Description: Validation experts Rich Yeaton and Kelly Thomas share their road-tested template for using existing process validation data to satisfy regulators. They discuss:
- How to use the template to zero in on the statistics that matter — and avoid wasting time validating things that don't matter;
- Understanding the nuances of the new FDA final guidance; and
- Implementing a plan that covers all the bases — process design, qualification and continued verification — in exactly the way the FDA expects.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Rich Yeaton, President, Atlantic Technical and Validation Services, LLC; and Kelly Thomas, Vice President of Quality, Atlantic Technical and Validation Services, LLC
Device Design and Risk Management
91 minutes
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
FDA User Fees, Drug Competition and Pricing
62 minutes
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.
Medical Devices: The Case for Quality
63 minutes
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
Medical Device Premarket Regulatory Pathways
66 minutes
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