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: 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
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
Recorded on: March 17, 2022
Description: Quality systems experts Dan Matlis, Sandra Rodriguez and Edward Armstrong, discuss using cloud applications to improve quality management. They address:
- Benefits of digitizing quality systems and documents;
- Good technology practices;
- Barriers to digital transformation; and
- Activities of the FDA’s Office of Digital Transformation.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Dan Matlis, Founder and President, Sandra Rodriguez, Senior Industry Analyst, Axendia; and Edward Armstrong, Director of Quality Assurance, Mustang Bio
Recorded on: Feb. 24, 2022
Description: Quality management experts Nate Henriod and Peter Harris of MasterControl discuss how the FDA has adapted its inspection practices to the pandemic environment and how manufacturers can cope with the changes. They cover:
- The challenges of remote inspections and how digitizing can help solve them;
- Benefits of remote oversight;
- What inspection practices may continue beyond the pandemic; and
- Best practices for managing remote audits and inspections.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Nate Henriod and Peter Harris, Senior Product Managers, MasterControl
Recorded on: Feb. 23, 2022
Description: If one of your biggest pain points right now is the in-bound pharma supply chain, this webinar is for you. It explains how to develop better ways of working that can end the supply chain issues impacting materials availability once and for all and covers:
- Why the improved change control approach is a fit for the needs of the industry and the needs of patients;
- How to implement the Quality by Design and ICH Q12 methods proposed by BioPhorum as part of an approach to the registration of innovative raw materials; and
- How being agile regarding change will alleviate the current situation for the availability of raw materials for your own production and for production across the industry.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Robert Brooks, Phorum Leader, BioPhorum Supply Partner
Recorded on: Feb. 17, 2022
Description: If you’re involved in developing gene and cell therapy products, the FDA and other regulators have made it clear: comparability studies are essential to product approval. This webinar explains:
- FDA requirements for comparability studies for gene and cell therapy products;
- Best practices for risk analysis and mitigation using comparability studies;
- How to design an effective comparability protocol for a gene or cell therapy product; and
- How to construct a statistical approach to comparability.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Scott R. Burger, Principal, Advanced Cell & Gene Therapy; William E. Janssen, Principal, WEJ Cell and Gene Therapy Consulting Services