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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 -
The Drug Supply Chain Security Act – Summarizing the Act and Its Effect on FDA Practice
Michael Walsh
Principal and International Managing Partner
Midgard Consulting Inc.
- The executive branch’s strategy and FDA’s pathway for global product supply chain security, safety, and quality
- Overview of the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act of 2013)
- FDA’s Implementation Plan, including timeline for Guidance
- Identifying the scope of the DSCSA
- Outlining the specifics:
- obligations to create a unique product identifier;
- establishing tracing and monitoring systems;
- developing detection and response protocols regarding counterfeit materials;
- understanding notification obligations;
- evaluating the effect of the act on the recall process; and
- penalties.