John Y. Lee is Executive Director of of EuroGMP AB and 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 Pharmaceutical Drug Association, the Center for Professional Advancement, Medical Manufacturing TechSource, Pharm Tech Conference, American Society for Microbiology and Technomics.

For information about Pharmaceutical Compliance Associates and PharmaNet , click the logos below:

Our courses with Mr John Y. Lee

» GMP Compliance Auditing #5201
» GMP Compliance and Auditing for Sterile Pharmaceuticals #5303
» Batch Record Review and Investigations #5301
» CGMP: Interpretation and Application #5302)
» GMP Compliance for Quality Control and Laboratory Operations #5202
» Validation and Qualification Compliance Requirements #5206

Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com