Speaking Engagement March 19–20, 2025

43rd Annual FDA Boot Camp

Event Detail
Cathy L. Burgess
March 19–20, 2025
8:00 AM - 5:00 PM Eastern Standard Time
New York Bar Association
New York, NY

Cathy Burgess will speak on the panel “cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (cGMPs) in the Post Approval Process.” Key topics will include:

  • Examining cGMPs and the scope of thier importance in pharmaceutical/biological product commercialization
  • Factoring cGMPs into the scope of the FDA’s authority
  • Exploring the scope of the FDA's cGMP Initiative and the concept of “risk-based” cGMPs
  • Unpacking the FDA’s Draft Strategy Document on Innovative Manufacturing Technologies
  • Conducting laboratory investigations in relation to cGMPs
  • Evaluating the costs and impacts of enforcement actions

For more information, click here.

Meet The Speakers
Media Contacts
Alex Wolfe
Communications Director

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