Speakers

Kai Kwok, PhD, is a Senior Pharmaceutical Quality Assessor (SPQA) in the Division of Product Quality Assessment I (DPQA I), Office of Product Quality Assessment I (OPQA I), Office of Pharmaceutical Quality (OPQ), CDER at FDA. In this role, he acts as the application technical lead for integrated quality assessment of generic drug products across various dosage forms. For the past decade at FDA, he has been reviewing ANDA, Bio-IND, and Pre-ANDA meeting packages involving complex drug products. He has also served as FDA liaison in the USP Packaging and Distribution Expert Committee, contributing to the development of USP packaging chapters and standards and as a member in developing FDA guidance on drug delivery performance for drug-device combination products. Prior to joining FDA, he spent over 10 years as a formulation scientist for drug product and process development in pharmaceutical industry. He earned his BS in Pharmacy from Temple University and PhD in Pharmaceutical Sciences from the University of Michigan.