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