Kim Huynh-Ba

Kim Huynh-Ba has 28 years of experience in the quality management system, project management, strategic drug development, and stability sciences.  She is currently the Managing Director of Pharmalytik (  Since 2003, she has provided consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree and supporting their quality systems. 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 (PittCon), 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 and Inspection, Good Manufacturing Practices (GMPs), ICH Quality Regulations, and Pharmaceutical Analysis. 

Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President.  Kim is a member of the USP Council of Expert chairing the Chemical Medicines IV Expert Committee. She is also the Chair of USP Good Documentation Practices Expert Panel and a member of the USP Organic Impurities of Drug Products Expert Panel and the USP Supplier Qualification Expert Panel.  She is also a member of the PQRI Stability Shelf-life working group and the PDA ANSI 01-0001- Enhanced Purchasing Controls working group.

Validated Cloud logo