Webinar: Stability Testing as a Quality Control Measure: Optimizing the Process throughout the Product Lifecycle
Assessing a compound’s stability is a complex and lengthy process with objectives varying by the development phase. A poorly designed stability study can cause delays that extend to years, create significant budget overruns and even result in product failure. Thus, stability testing requires scientific expertise and very specialized experience in order to minimize development costs and avoid severe consequences. This webinar will discuss the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.
As Executive Director of Analytical Services of CMC for Frontage Laboratories, Dr. Dong is responsible for overall operations, scientific achievement and regulatory rigor of analytical support of drug product development services to the clients. He oversees analytical method development and validation, stability studies and routine testing in support of clients’ IND/NDA/ANDA needs. Gary has over 20 years of industry experience in analytical area under both R&D and QC environments. His technical expertise includes hands on experience with FDA/EMA/Health Canada audits/inspections, in-depth knowledge of analytical method development and validation and stability study, systematical understanding of FDA/HPFB/ICH regulatory guidelines, and cGMP/GLP requirements for stability study and analytical support work of clinical studies and commercial manufacturing. His most recent position was with STA, Wuxi Apptech, Shanghai, China, where he served as Executive Director of newly established Analytical R&D operation in support of the drug product development to a large base of clients. Prior to that, Gary also worked as laboratory supervisor, manager and director with other CRO/CMO organizations in Canada and USA, such as Patheon, Halo, PSP and CPL.
Dr. Dong earned his M. Sc. and Ph.D. from University of Guelph, Canada, in Chemistry and Biochemistry, and B. Sc. from Peking University in Beijing, China, in Environmental Chemistry.