Rakhi B. Shah, PhD

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FDA/CDER/OPQ
Branch Chief (Acting), Office of Process and Facilities
Dr. Rakhi B. Shah comes from Office of Process and Facilities where she is employed as an acting branch chief. Her primary responsibilities include leading the branch on manufacturing process and facility evaluations. She has also participated on Pre-approval, post-approval, and surveillance inspections. Her interests include dosage form design and development of conventional and biotech derived drugs, application of Quality by Design, Process Analytical Technology, use of Design of experiments, risk management, novel drug delivery systems as well as facility evaluations & inspections. She has received numerous internal awards at FDA as well as various external awards. Prior to joining OPF, she was working as a team leader in Office of Generic Drugs in Chemistry division and lab scientist in research labs at FDA. She received her Ph.D. in Pharmaceutical Sciences from Texas Tech University. She has also earned M.S. in Bioprocess Tech and B.S. in Pharmaceutical Sciences from Mumbai Univ, India. She has co/authored 40+ publications and 8 book chapters and has presented her research findings in various international meetings. She has also been invited as a speaker at various national and international meetings. She serves as the reviewer for numerous journals.