Kim Huynh-Ba
Founder & Technical Director, Pharmalytik

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Biography:

Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree. She also has provided support to build Quality Management Systems for many clients in US and abroad. In 2011-2013, she took a sabbatical from Pharmalytik to join the U.S. Pharmacopeia (USP) Convention as the Director of Pharmacopeial Education Department, 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 numerous 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 pharmaceutical analysis, quality audit and GMPs graduate courses.

Kim is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. She was recently elected as a member of the USP Council of Experts for the 2015-2020 cycle and Chair the Chemical Medicines IV Expert Committee. She is also the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel. Kim co-chaired the organization and the development of the Regulatory Sciences 101 and Stability 101 eLearning courses for AAPS launched in 2014 and 2015.

Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. Kim is a member of the Editorial Board of AAPS Open Access Journal. 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).