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Welcome to Drug Delivery Leader Live – a dynamic arena in which our audience and community can hear from and engage with leading thinkers in the drug delivery space.

In these sessions, Chief Editor Tom von Gunden and others on our editorial staff are joined by guest experts from the field to address timely, impactful topics, challenges, and issues facing drug delivery professionals. These discussions often include interactive Q&A and collaborative conversation among panelists and audience participants. Each Drug Delivery Leader Live session is archived for access at any time by Drug Delivery Leader site users.

HUMAN FACTORS RISK ANALYSIS: LEVERAGING URRA AND UFMEA TOOLS

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Human Factors Risk Analysis: Leveraging URRA And uFMEA Tools

Drug Delivery Leader Executive Editor Fran DeGrazio and Chief Editor Tom von Gunden welcome human factors experts Natalie Abts and Shannon Hoste to discuss best practice approaches to human factors risk analysis for combination products and medical devices.

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THE FDA GUIDANCE ON EDDO: WHAT TO KNOW, WHAT TO DO

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The FDA Guidance on EDDO: What to Know, What to Do

Drug Delivery Leader Executive Editor Fran DeGrazio welcomed combination product regulatory experts in a candid conversation about the FDA’s recent draft guidance on Essential Drug Delivery Outputs (EDDO). 

This dynamic discussion covere...

NEW FDA QMSR: ITS ROLE IN PART 4 COMPLIANCE FOR COMBINATION PRODUCTS

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New FDA QMSR: Its Role In Part 4 Compliance For Combination Products

The FDA’s release of the new Quality Management System Regulation (QMSR) significantly revises 21 CFR Part 820 Quality System Regulation and, in turn, Part 4 CGMP for combination products. The inclusion of ISO 13485 through reference brings the impact of global harm...

MEET YOUR HOSTS

 

Chief Editor and Community Director Tom von Gunden ensures that Drug Delivery Leader provides its audience with indispensable resources for staying current on the industry’s most innovative thinking.

 

Executive Editor Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry. Fran is also President & Principal Consultant for Strategic Parenteral Solutions LLC and previously held numerous strategic and technical roles at West Pharmaceutical Services.