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Sarah Tanksley is a Pharmaceutical Quality and Compliance Consultant with nearly 20 years of experience in the FDA, the NIH, and various consulting firms. She began her career as a government biologist assigned to the U.S. Army, and then later to a non-clinical Laboratory of Immunology at the National Institute of Allergy and Infectious Diseases. Prior to founding Tanksley Consulting Group, Inc., she worked as a Principal Consultant at PAREXEL Consulting, and as a reviewer and inspector with FDA. She has a broad range of experience and expertise with small molecule products as well as biologics and advanced therapies, in particular sterile/aseptic injectable products. She teaches courses in FDA Regulation and GMP to graduate Biotechnology students at Georgetown University and Johns Hopkins University, and she has trained audiences, including the FDA, on GMP and data integrity topics. She holds an M.S. in Biochemistry and Molecular Biology from Georgetown University, a B.S. in Biology from the College of William and Mary, and an M.S. in Regulatory Science from Johns Hopkins University.