Mr. Kenneth J. Christie
(Associate FDA Consultant)Mr. Kenneth J. Christie is the Chief Operating Officer of VTS Consultants, Inc., USA, a globally recognized consulting firm specializing in GMP, validation, and regulatory compliance services for the pharmaceutical, biotechnology, and life sciences industries. With more than 40 years of international experience, he has established himself as a subject matter expert in sterile manufacturing, validation, aseptic processing, and quality systems.
Since joining VTS Consultants in 1998, Mr. Christie has directed corporate growth strategies, managed diverse client projects, and performed over 250 supplier and GxP quality system audits (GMP, GLP, GCP, ISO, and AATB) across the United States, Europe, Middle East, and Asia. His expertise includes guiding clients through FDA 483 observations, CAPA investigations, warning letters, and consent decree remediations. He has also played a key role in Pre-Approval Inspections (PAIs) and regulatory compliance assessments for leading pharmaceutical and biotech companies worldwide.
Earlier in his career, Mr. Christie held senior roles at Parke-Davis Pharmaceuticals (Warner-Lambert) as Validation Manager and at Wyeth Laboratories as Influenza Production Supervisor, where he led large-scale vaccine production and validation programs.
A respected international trainer and speaker, he has delivered programs for ISPE, PDA, AAPS, IPA Canada, and Shanghai NovoSciences on topics including cGMPs for sterile products, aseptic processing, change control, environmental monitoring, and medical device quality systems. He is also the author of several technical publications on aseptic processing challenges.
Mr. Christie holds an Executive MBA from Michigan State University and a B.A. in Biology with a Chemistry Minor from Shippensburg University, Pennsylvania. He is an active member of the Parenteral Drug Association (PDA), the American Association of Pharmaceutical Scientists (AAPS), and the International Society of Pharmaceutical Engineers (ISPE), where he contributes to the Examination Development Committee.
