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13/03/2024 14/03/2024 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2024
SpringHill Suites NY Manhattan Times Square South, New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. SpringHill Suites NY Manhattan Times Square South, New York, NY true DD/MM/YYYY 1440 use-title -
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13/03/2024 14/03/2024 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2024
SpringHill Suites NY Manhattan Times Square South, New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. SpringHill Suites NY Manhattan Times Square South, New York, NY true DD/MM/YYYY 1440 use-title -
cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval Process
Seth A. Mailhot
Partner
Husch Blackwell LLP
Joshua M. Oyster
Partner
Ropes & Gray LLP
- 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