Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and USP regulatory compliance directives for analytical data submissions.
Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and USP regulatory compliance directives for analytical data submissions. Areas of concentration include conformity assessment; analytical method optimization during development; case studies in the improvement of validation characteristics; data integrity and statistical evaluation of analytical data; and more.
Scientists, managers, and technicians involved in methods validation and optimization, analytical research and development, meeting FDA requirements and regulations, validating analytical methods, application of newer analytical methods, and those involved in quality control, quality assurance, and quality assessment.
Temple University Center City
1515 Market Street
Philadelphia, PA 19102
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Kim Huynh-Ba is the Managing Director of Pharmalytik, a consulting and training organization. She has almost 30-yr experience in Quality systems, strategic drug development, and stability sciences. She is a Council of Expert of US Pharmacopeia, where she chairs the Chemical Medicines IV expert committee. She is also a member of the USP Organic Impurities of Drug Products Expert Panel. She is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology, where she teaches Quality Audit, GMPs, ICH quality guidelines, and Pharmaceutical Analysis. She is the editor of the two well-known stability handbooks and is completing a new manuscript entitled “Analytical chemistry: A handbook of Pharmaceutical GMP Laboratories.”