Qualify a New Laboratory to Perform Analytical Testing of Pharmaceutical Products
Presented by Kim Huynh-Ba, Pharmalytik, LLC
Tuesday, August 3, 2021 ◉ 1:00 pm to 3:00 pm EST
TARGET AUDIENCE: Analytical Chemists, Regulatory Affairs, Quality Assurance, Quality Auditors, Compliance personnel, Quality Control, R&D analytical scientists.
COURSE DESCRIPTION: Analytical methods are a major tool in pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are typically developed at one site and then transferred to one or more sites for analytical testing. Qualifying a new analytical laboratory is a critical activity that would significantly impact the launch of a product. This concise session will discuss different strategies to qualify a new laboratory to perform analytical testing and a quality system to maintain GMP compliance throughout the product lifecycle.
About Kim Huynh-Ba
Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has almost 30-year experience in the Quality system, strategic drug development, and stability sciences. She is a Council of Experts of US Pharmacopeia (2015-2020), where she chairs the Chemical Medicines IV Expert Committee. She is also a member of the USP Organic Impurities of Drug Products Expert Panel. Kim was the chair of the USP Good Documentation Practices Expert panel.
Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology, where she teaches GMPs, Quality Audit, ICH quality guidelines, and Pharmaceutical Analysis. She is the editor of several book volumes, “Handbook of Stability Testing of Pharmaceutical products”, “Stability Testing to Support Global Markets,” and the upcoming “Analytical chemistry: A handbook of Pharmaceutical GMP Laboratories.”