Speakers

Sharmista Chatterjee is currently the Division Director in Division of Pharmaceutical Manufacturing Assessment  III, within FDA’s Office of Pharmaceutical Manufacturing Assessment (OPMA). Sharmista has been with the FDA since 2006. During her tenure she has been actively involved in many agency initiatives that include Quality by Design (QbD), Emerging Technology Program (ETP), Advanced Manufacturing Technology Designation (AMTD), KASA, Continuous Manufacturing, and in the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) . Prior to joining the agency in 2006, she spent around 10 years in industry. Her industry experience was primarily in process development and modeling in diverse areas that ranged from consumer goods to pharmaceuticals with companies such as United Technologies Corporation (now Raytheon), Procter and Gamble (P&G), and Forest Laboratories (now AbbVie). She received a bachelor’s degree in Chemical Engineering from Indian Institute of Technology and a PhD in Chemical Engineering with a co-major in Biomedical engineering from Iowa State University.