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Wednesday, April 11 • 3:30pm - 5:00pm
Session AA - GMP Track

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AA-1  Letters from FDA: Warning Letters, 90-Day Letters and the trends behind them

Abstract: TBA

Category: TBA

Level of Content: TBA

AA-2  30-minute interactive audience Q&A


Megan Callan

Manager Regulatory Compliance, Charles River Laboratories
Megan Callan is the Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GLP and GMP testing conducted at the Cleveland, OH site. She started her career working in microbiology laboratories for pharmaceutical/biotech... Read More →

avatar for Sarah Barkow

Sarah Barkow

U.S. Food and Drug Administration
Sarah Barkow is a Team Lead for Manufacturing Quality Guidance and Policy in CDER’s Office of Manufacturing Quality at the FDA. She was co-lead author on the recently released draft guidance for industry, Data Integrity and Compliance With CGMPs. Dr. Barkow holds her Ph.D. in Physical... Read More →

Wednesday April 11, 2018 3:30pm - 5:00pm PDT
Platinum 1&2