has almost 28 years of experience in Good Manufacturing Practices (GMPs), Quality Management Systems (QMS), strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. 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 teaching GMPs, pharmaceutical analysis and quality audit. Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. She is a member of AAPS Publication Committee and chair of the Stability Focus Group, and serves on the steering committees of several focus groups. She is a member of USP Council of Experts and Chair of the Chemical Medicines 4 Expert Committee (2015-2020).
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 has been an instructor with the American Chemical Society for ten years.
Courses with Kim Huynh-Ba
- Introduction to Pharmaceutical Analysis
- Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices
- Effective Auditing/Inspection Process for Pharmaceutical Laboratories
- Critical cGMP and ICH Regulations for Pharmaceutical Laboratories
- Conducting Successful OOS/OOT Investigations for Analytical Testing
- Analytical Method Transfer of Pharmaceutical Products