Kim Huynh-Ba has 28 years of experience in quality management systems, project management, strategic drug development, and stability sciences. She currently is the Managing Director of Pharmalytik (www.pharmalytik.com). Since 2003, she has provided consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree. Her clients are from various sizes of pharmaceutical companies in the US and abroad. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups.
She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching Quality Audit, Good Manufacturing Practices (GMPs), ICH regulations, and Pharmaceutical Analysis.
Kim is a member of the US Pharmacopeia (USP) Council of Expert chairing the Chemical Medicines IV Expert Committee (2015-2020). She is also the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of the USP Organic Impurities Expert Panel (2012-present). She is also a member of the PQRI Stability Shelf-life working group.
Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets (2010). She is working on a new manuscript entitled “Analytical chemistry: A handbook of Pharmaceutical GMP Laboratories.”