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The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
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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: 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
Recorded on: April 27, 2022
Description: Device compliance expert Kristen Grumet walks through the FDA’s new proposed Quality Management System Regulation, explaining its provisions and impact. She discusses:
- Conceptual differences between the current Quality System Regulation and ISO 13485;
- Changes in definitions of key terms;
- Which quality system requirements will be more explicit when aligned with ISO 13485; and
- The differences between FDA inspections and Notified Body audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kristen Grumet, Senior Vice President of Regulatory Compliance, Greenleaf Health
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections
90 minutes
Recorded on: April 20, 2022
Description: Get control of your data by learning the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks. You’ll cover:
- The legal basis of FDA records access authority, including what FDA can’t access;
- Types of documents commonly requested during inspections;
- Problems and pitfalls to avoid; and
- The Top 10 questions to ask about your archival process.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David L. Chesney, Principal, General Manager, DL Chesney Consulting, LLC
Making the Digital Quality Journey in Cell and Gene Therapy: From Bench to Bedside to Benefit
57 minutes
Recorded on: April 20, 2022
Description: Three digital transformation experts discuss the long-term strategy and approach to quality that is needed for cell and gene therapy development. Topics include:
- Emerging treatments;
- Traceability;
- Complex value chains; and
- Specialized talent needs and resource shortages.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Vinod Nela and Rameez Abdul Basheer, Deloitte Smart Quality, and Edward L. Armstrong, Senior Director of Quality Assurance, Mustang Bio
Recorded on: March 30, 2022
Description: A panel of quality experts discusses applying industrial transformation methods to quality systems management. Topics include:
- The stages of industrial transformation;
- Digital transformation of biotech companies’ quality systems;
- The quality management maturity curve; and
- Using data and analytics to drive quality system improvement.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Matthew Littlefield, Cofounder and President, LNS Research; Vivek Murugesan, Senior Research Associate, LNS Research; Jason Boyd, Senior Director, Vault LIMS
Recorded on: March 23, 2022
Description: This webinar shows you how to incorporate cybersecurity into your quality system and defend it to interested third parties. It covers:
- 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;
- How addressing cybersecurity risk relates to product risk management; and
- What regulatory literature currently exists globally and some of the ways they compare to each other.
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: March 22, 2022
Description: A panel of FDA inspection experts discusses the current and future state of the agency’s drug/biologics facility inspection activities. Topics include:
- Differences between remote and on-site inspections;
- Requirements for virtual inspection sessions; and
- Preparing for FDA records requests.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Cynthia Schnedar, Principal of Regulatory Compliance, Greenleaf Health; Steven J. Lynn, Executive VP of Pharmaceuticals, Regulatory Appliance Associates; Bob Rhoades, Managing Partner, Validant
Recorded on: March 17, 2022
Description: Medical devices expert Seyed Khorashahi discusses a risk-based approach to FDA inspection preparation, including:
- New alternative inspection tools the FDA is using; and
- What FDA investigators will focus on in 2022 and beyond.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Seyed Khorashahi, Executive Vice President of Medical Device and CTO, Regulatory Compliance Associates