Speaker: Dr. Chung Chow Chan 

Seminar will be conducted online via Zoom @ 5:30 pm EDT

Abstract

The purpose of stability testing in the pharmaceutical industry is to understand how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light.  The data that are collected from the stability studies will help to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.  This presentation will provide an overview of development and formal stability studies that will be used during the development of a drug product.

About Speaker

Dr. Chung Chow Chan is an expert in development of GxP quality programs and analytical method development/validation. In addition to his role at Covar, he is a member of the Prescription/Non-Prescription Stakeholders and General Chapters Project Teams for the United States Pharmacopeia.

Dr. Chan was Senior Director of Project/Program Management and Analytical Services at Azopharma, where he led validation strategies and Phase I development programs. Before Azopharma, Dr. Chan was a Technical Manager and Principal Research Scientist at Eli Lilly, where he led early/late development projects, method validations, and IND/NDA submissions. Dr. Chan also worked at Glaxo as a Research Scientist and Manager.

Dr. Chan received his B.Pharm. (Hons) from the University Sains Malaysia, Malaysia, M.S. in Medicinal Chemistry from Dalhousie University, Canada, and Ph.D. in Medical and Analytical Chemistry from Purdue University, Indiana. He is also the author and editor of three books, most recently “Therapeutic Delivery Solutions” (John Wiley & Sons, 2014), and is a Registered Pharmacist in Ontario, Canada.