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.

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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.

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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.

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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.

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Speaker: Kristen Grumet, Senior Vice President of Regulatory Compliance, Greenleaf Health

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.

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Speaker: David L. Chesney, Principal, General Manager, DL Chesney Consulting, LLC

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.

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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.

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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.

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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.

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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.

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Speaker: Seyed Khorashahi, Executive Vice President of Medical Device and CTO, Regulatory Compliance Associates