#245: Risk-Based Inspections
Chair
Division Director (Acting), Div. of Inspectional Assessment, OPF, OPQ, CDER, FDA
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD...
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Speakers KB
Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Karen Bossert is the Vice-President, Scientific Affairs at Lyophilization Technology, Inc. She has over 25 years of experience in pharmaceutical manufacturing and development. She received her Bachelor of Science degree in Pharmacy and her Doctorate in Pharmaceutics. Karen has authored...
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Acting Director, Office of Process and Facilities, OPQ, CDER, FDA
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities. Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in OPS. He was also a Division Director and CMC Team Leader in OGD. Prior to joining the FDA...
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Tuesday June 28, 2016 2:00pm - 3:15pm EDT
111AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA