November 8-10, 2021 | Virtual Conference

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Speakers

Bob Iser, MS

Senior Vice President, Global Quality Management
Amneal Pharmaceuticals

Bob Iser is the Senior Vice President responsible for global quality management at Amneal (including site quality and global quality systems oversight) and has more than 20 years of U.S. FDA and Biopharmaceutical industry experience in product development, manufacturing, quality systems, policy and procedure development and validation of analytical methods. Prior to joining Amneal, Bob served as Vice President, Regulatory Consulting Services for Parexel International, where he led the Strategic Compliance Team advising clients on developing global regulatory strategies. He is also a former 14-year veteran of the U.S. FDA/Center for Drug Evaluation and Research (CDER). During his tenure with FDA, he served various leadership roles of increasing responsibility across several offices at the Center for Drug Evaluation and Research (CDER), including the Office of Pharmaceutical Quality, Office of Pharmaceutical Science, and Office of Generic Drugs (OGD). Prior to joining FDA, Bob served in Quality Control leadership roles for Eurand, Inc. – at the time a privately held pharmaceutical company. He holds an M.S. in Chemistry from Wright State University and a B.S. in Chemistry from Muskingum College.

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