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Thought Leadership

Speaker, "Discovering the Unique Role of Current Good Manufacturing Practices ('cGMPs') in the Post Approval Process," ACI's FDA Boot Camp

 
Speaking Engagements

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.

Professional:

Seth A. Mailhot

Partner
 

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