Recorded on: Jan. 22, 2020

Description: Computer system validation expert David Harrison shares best practices and available options for validating spreadsheets. He discusses:

• FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
• How to determine spreadsheet validation gaps the FDA targets;
• How to choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
• How to plan, manage and resource an effective project.

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Speaker: David Harrison, Principal Consultant, CSV Compliance

Recorded on: Jan. 21, 2020

Description: Regulatory expert Grace Fu Palma provides an update on medical device regulatory reform in China. She discusses:

• New postmarket surveillance regulations and implications in adverse events and recalls reporting;
• What the regulations and requirements forecast for overseas inspections; and
• Common issues in GMP compliance.

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Speaker: Grace Fu Palma, CEO, China Med Device

Recorded on: Jan. 14, 2020

Description: Compliance experts Cynthia Schnedar and Liz Oestreich discuss issues surrounding data integrity. Topics include:

• Developing an organizational culture of quality that ensures data integrity;
• FDA enforcement activity; and
• Recent data integrity failures in the news.

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Speakers: Cynthia Schnedar, Executive Vice President, and Liz Oestreich, Vice President, Greenleaf Health

Recorded on: Jan. 10, 2020

Description: GxP expert David Chesney shares best practices for creating effective new SOPs for electronic document management or improving existing SOPs. He discusses:

• The legal basis of FDA records access authority;
• The types of documents commonly requested during inspections;
• The perils of emails as GxP documentation, and how to avoid them; and
• The impact of the shift to real-time electronic review of documents during inspections.

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Speaker: David Chesney, Principal and General Manager, DL Chesney Consulting, LLC

Recorded on: Dec. 18, 2019

Description: : Consultant and former FDA investigator Ricki Chase explains how to navigate the FDA’s Adverse Event Reporting System. She discusses:

• The difference between serious unexpected and serious expected events;
• Common inspection observations related to adverse events; and
• What not to report.

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Speaker: Ricki Chase, Executive Director, Lachman Consultant Services

Recorded on: Dec. 17, 2019

Description: A panel of quality systems experts discuss the benefits of using cloud technology solutions. They cover:

• Regulatory impact;
• Hybrid cloud approach; and
• Validating cloud solutions.

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Speakers: Ashley Wentworth, Director of Strategy, Vault Quality, Veeva Systems; Robert Lorence, Managing Director, PwC Consulting; Jhumki Sen, Senior Manager, PwC Consulting

Recorded on: Dec. 16, 2019

Description: Biologics development Scott Burger presents strategies for successful BLA submissions. He discusses:

• FDA requirements for cell therapy or gene therapy BLAs;
• What reviewers in the Office of Tissues and Advanced Therapies expect to see; 
• How a cell or gene therapy BLA fits into the framework of the common technical document; and
• How the earlier stages in development affect the content of the BLA.

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Speaker: Scott Burger, Principal, Advanced Cell and Gene Therapy

Recorded on: Dec. 12, 2019

Description: Device industry veteran Jon Speer presents best practices, tips and pointers for internal company change control processes and practices. He discusses:

• The different types of change and how each should be managed;
• How to assure a risk-based approach to change management; and
• How technology solutions can help streamline change management.

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Speaker: Jon Speer, Co-founder and Vice President of QA/RA, Greenlight Guru

Recorded on: Dec. 10, 2019

Description: A panel of experts discusses the pharmaceutical regulatory climate in the coming year. They cover:

• The impact of the new FDA commissioner;
• Drug pricing;
• Drug importation; and
• Generics competition.

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Speaker: Wayne Pines, President of Healthcare, APCO Worldwide; John Kamp, Washington Counsel, Coalition for Healthcare Communication; Kevin Madagan, Partner, Reed Smith; Tish Pahl, Principal, OFW Law

Recorded on: Dec. 9, 2019

Description: Intellectual property experts Chad Landmon and Neema Kumar explore FDA and congressional initiatives to promote generic drug competition. They discuss:

• Implementation of the FDA’s Drug Competition Action Plan;
• Pathways to expedited approval of generic drug applications; and
• How to obtain 180-day exclusivity.

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Speakers: Chad Landmon, Chair, FDA and IP practice groups, Axinn, Veltrop & Harkrider LLP; Neema Kumar, Senior IP Counsel, Hikma Pharmaceuticals USA