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10/03/2015 11/03/2015 America/Toronto American Conference Institute's 24th FDA Boot Camp American Conference Institute’s 24th FDA Boot Camp
March 10 – 11, 2015
Doubletree Suites by Hilton Times Square, New York, NY
Please visit https://staging.americanconference.com/fda-boot-camp-711l15-nyc/ for more information and updates. Doubletree Suites by Hilton Times Square, New York, NY true DD/MM/YYYY 1440 use-title -
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10/03/2015 11/03/2015 America/Toronto American Conference Institute's 24th FDA Boot Camp American Conference Institute’s 24th FDA Boot Camp
March 10 – 11, 2015
Doubletree Suites by Hilton Times Square, New York, NY
Please visit https://staging.americanconference.com/fda-boot-camp-711l15-nyc/ for more information and updates. Doubletree Suites by Hilton Times Square, New York, NY true DD/MM/YYYY 1440 use-title -
cGMPs: Drugs and Biologics (current Good Manufacturing Practices)
Kirsten Mayer
Partner
Ropes & Gray LLP (Boston, MA)
- Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/biological product commercialization
- Looking at how cGMPs factor into the scope of the FDA’s authority and history
- Exploring the scope of the FDA’s cGMP Initiative and how the concept of “risk-based” cGMPs is defined
- Defining the concept of validation
- How are laboratory investigations in relation to cGMPs conducted?
- Defining the term “quality systems”
- How are cGMPs factoring into products litigation?
- Evaluating the cost of enforcement actions: what happens to company stock when there is an announcement of an enforcement action?