cGMPs: Drugs and Biologics (current Good Manufacturing Practices)
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?