November 9-11, 2020 | Virtual Conference


Mamta Kapoor, PhD

Chemist/Quality Assessor, Division of Liquid-Based Products I (DLBP I), Office of Lifecycle Drug Products (OLDP), OPQ CDER

Dr. Mamta Kapoor, Ph.D., is currently working as a Product Quality Assessor in the Office of Pharmaceutical Quality (OPQ) at the US Food and Drug Administration (U.S. FDA). Prior to joining the Agency, Dr. Kapoor received her B.S. degree in Pharmacy from College of Pharmacy, Delhi, India and Masters in Pharmaceutics from NIPER, Punjab India. She earned her Ph.D. in Pharmaceutics from the University of Connecticut in lipid formulations for gene delivery, and worked as a Postdoctoral Fellow at the University of Minnesota. Dr. Kapoor has several publications, patents and book chapters, in the field of formulation and drug delivery. For her research work she received several accolades such as ‘University of Connecticut Outstanding Senior Women Achievement Award’ in 2012, ‘AAPS Graduate Student Symposium Awards in Biotechnology’ in 2012 and ‘Baxter Young Investigator Award’ in 2014. In 2014, Dr. Kapoor was invited to talk at and as ‘Young Innovators in the Spotlight’ organized by International Foundation of Pharmaceutical Manufacturers and Associations (IFPMA). Since past 6 years she has been working at the FDA assessing Chemistry Manufacturing and Controls (CMC) aspects in applications for generic drug products such as oral, parenteral, ophthalmic, including drug-device combination products. She has several regulatory science publications related to nanotechnology, and has received 2016 CDER Regulatory Science Excellence Award and 2020 CDER Honor Award, in recognition to her contributions towards regulatory science within U.S. FDA.

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