cGMPs: Drugs and Biologics (current Good Manufacturing Practices)

September 19, 2014 8:15am


Kirsten Mayer
Ropes & Gray LLP (Boston, MA)

  • Examining cGMPs (current Good Manufacturing Practices)and the scope of their importance in pharmaceutical/biological product commercialization
  • Looking at how cGMPs factor into the scope of the FDA’s authority and history
  • Exploring the scope of the FDA’s cGMP Initiative and how the concept of “risk-based” cGMPs is defined
  • Defining the concept of validation
  • How are laboratory investigations in relation to cGMPs conducted?
  • Defining the term “quality systems”
  • How are cGMPs factoring into products litigation?
  • Evaluating the cost of enforcement actions: what happens to company stock when there is an announcement of an enforcement action?