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Home » Webinars

Now get all the training you need – all in one place, and all for one low price!

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.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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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BUY NOW Single-User 1-Year Unlimited Access $1,297

Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Muctar Ibrahim, Content Licensing Manager at mibrahim@wcgclinical.com or +1 484.351.9954 to receive a custom quote.

Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.

If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.

Webinar Training Pass

Real-World Evidence in Medical Device Submissions: What Regulatory, Compliance & Quality Professionals Need to Know
69 minutes

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

Communicating Directly with Consumers on Social Media: What You Must Know About FDA and FTC Ad Promo Rules
88 minutes

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

Strategies and Best Practices for Transforming Enterprise Training
59 minutes

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

FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers
65 minutes

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

Drive Efficiency and Insights by Turning Quality Data into an Asset
61 minutes

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

Medical Device Cybersecurity: Latest Developments
75 minutes

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

Prepare Your Drug/Biologics Facility for the New FDA Inspection Model: Will it Be Remote/In-Person or Hybrid?
71 minutes

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

FDA Medical Device Inspections in the Post-Pandemic World: Are You Ready for New Approaches and Methods?
78 minutes

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

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