Our Instructors

Anne Marie Dixon is the Managing Partner of Cleanroom Management Associates, a consulting firm that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management. She has been actively engaged in the field of contamination control for over two decades with extensive experience in the areas of training, technical writing, strategic consulting, facility start-up, construction protocols and process optimization.

Ms. Dixon is the first recipient of the James P. Agalloco Award for Excellence in Training and is an active member of the PDA, IEST, ISPE, ASQ, SSA and AMA. She is also an ISO 9000 trained auditor. She is the head fo the U.S. Technical Advisory Group - TC 209 and represents the USA on the ISO Technical Committee 209 on Cleanrooms and Associated Controlled Environments.

John Y. Lee is Executive Director of Pharmaceutical Compliance Associates, North Massapequa, New York. Prior to joining PCA, Mr. Lee held positions as QA/QC Director at Altana, Inc., Melville, New York; QA Manager at Organon, Inc., West Orange, New Jersey; GMP Compliance Associate at Ortho Pharmaceuticals, Raritan, New Jersey; and Investigator at the FDA’s Newark District Office. He has a B.A. degree in Biology from New York University and a M.B.A. 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, and served as course instructor, 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 and American Society for Microbiology and Technomics.

Karen Zink McCullough is principal consultant at MMI Associates. She has worked in the field of microbiological testing and control for over 30 years. She is a member of the United States Pharmacopeia Expert Committee on Microbiology General Chapters, and is a US delegate to ISO TC209 WG02, charged with the revision of ISO 14698, the biocontamination standard. She is an international expert in the field of bacterial endotoxin testing (BET), and has just edited a book on the topic. Ms. McCullough is a frequent speaker on the BET and other areas of Microbiological Quality Control including sterility testing, environmental monitoring, OOS investigations and laboratory audits.

Ms. McCullough has over 20 years of experience in the development and implementation of pharmaceutical and medical device Quality Systems. She has executed many GMP audits, and has worked on mitigation efforts including root cause and CAPA for consent decrees, warning letters and external audit findings.

Ms. McCullough holds a B.A. degree in Bacteriology from Rutgers University and an M.S. degree in Molecular Biology from the University of Oregon.

Steven L. Nail, Ph.D. is currently a Senior Baxter Research Scientist in the R&D organization at Baxter Pharmaceutical Solutions in Bloomington, IN, where he is responsible for scientific and technical leadership in the formulation and manufacture of parenteral products.

He is Chairman of the USP Committee of Experts in Parenteral Products and a member of the Executive Committee of the Counsel of Experts for USP. He is an adjunct professor at Purdue University, and is a Fellow of the American Association of Pharmaceutical Scientists.

Edward H. Trappler is president of Lyophilization Technology, a contract research and consulting company. Previously, he was a systems application engineer for Hull Corp., and prior to that he worked in product development, toxicological supplies, clinical manufacturing and sterile product production for American Home Products and Johnson & Johnson. He has a B.S. in chemistry from Trenton State College.

Mr. Trappler has presented and published a number of papers and is involved in educational forums in lyophilization, both within the United States and internationally. He is an active member of the Parenteral Drug Association and the chairman of their Validation of Lyophilization task force. He is also a member of the American Association of Pharmaceutical Scientists and the International Society of Pharmaceutical Engineers.