Branch chief, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER
Silver Spring, Maryland
Dr. Rakhi Shah is a Branch Chief in the Office of Pharmaceutical Manufacturing Assessment. She is leading OPMA’s efforts of developing a novel risk-based assessment framework for conducting risk based assessments. She also represents the office in various cross-functional initiatives with ORA, Office of Compliance, and other sub-offices within OPQ such as development of New Inspection Protocol Program (NIPP) and Knowledge Aided Structure Assessment (KASA). She has a PhD in Pharmaceutical Sciences from Texas Tech University and, MS in Bioprocess Technology and BS in Pharmaceutical Sciences from ICT, Mumbai, India. She has co-authored more than 40 publications and 10 book chapters and has presented at various international conferences.
Monday, November 2, 2020
11:30 AM – 12:00 PM ET