Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

Kim Huynh-Ba is the Executive Director and CEO of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree. She is the editor of the well known “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” and “Pharmaceutical Stability Testing to Support Global Markets” (2010). She has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she was the Director of USP Pharmacopeial Education Department, where she was responsible for their education programs worldwide.

Kim is a member of the USP Council of Experts for the 2015-2020 cycle and is the 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 is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President.

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 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, U.S. Pharmacopeia (USP) and many other international training groups.