cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process

September 15, 2022 8:45am

Seth A. Mailhot
Partner
Husch Blackwell LLP (New York, NY)

Veleka R. Peeples-Dyer
Chief Legal Officer, Corporate Secretary and Chief Compliance Officer
Opentrons Labworks, Inc. (Washington, DC)

  • Examining cGMPs (current Good Manufacturing Practices) and the scope of their 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
  • Conducting laboratory investigations in relation to cGMPs
  • Understanding the influence of cGMPs in products liability litigation
  • Evaluating the costs and impact of enforcement actions