John Y. Lee

John Y. Lee is Executive Director of Pharmaceutical Compliance Associates, an organization specializing in pharmaceutical compliance consulting, auditing, quality assurance, validation, and training. Prior to joining PCA, Mr. Lee held positions as Quality Assurance and Quality Control Director at Altana, Inc., Melville, New York; Quality Assurance Manager at Organon, Inc., West Orange, New Jersey; GMP Compliance Associate at Ortho Pharmaceuticals, Raritan, New Jersey; and Field Investigator at the FDA’s Newark District Office. He has a B.A. degree in Biology from New York University and an MBA in Pharmaceutical Studies from Fairleigh Dickinson University.

Mr. Lee has lectured and published extensively on the topics of GMP compliance and auditing, quality assurance, validation, lyophilization, aseptic processing and filtration, clean rooms and pre-approval inspections. He is presently a course instructor for PharmaNet Inc. and served as symposium chairman, moderator and speaker for various professional organizations including the Parenteral Drug Association, the Centre for Professional Advancement, Medical Manufacturing TechSource, Pharm Tech Conference, American Society for Microbiology and Technomics.


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