Seth Mailhot will present "Discovering the Unique Role of Current Good Manufacturing Practices ('cGMPs') in the Post Approval Process," at ACI's FDA Boot Camp on Thursday, March 24, 2022.
Topics
- 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
For more information, visit the event website.