Cathy Burgess will speak at ACI’s FDA Boot Camp as it returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices.
Cathy's session, “cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (cGMPs) in the Post Approval Process,” will cover:
- 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
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