Mr. Kenneth J. Christie,
Chief Operating Officer
Kenneth Christie joined VTS in 1998 and has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.
Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.
Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.
Mr. Kayvan Khatami
Vice President of Operations
Mr. Khatami joined VTS in 1995 and has over 20 years of experience and has been instrumental in leading VTS to its current position as one of the leading Validation and Compliance services in the United States and Puerto Rico.
During this time, Mr. Khatami has consulted to a majority of the country’s premier pharmaceutical and biotechnology companies as well as many smaller and start-up companies in the US and Puerto Rico. Mr. Khatami’s achievements include:
- Managed major turn-key validation projects in the US and Puerto Rico.
- Managed the qualification effort of a start up company leading to successful plant expansion and subsequent FDA approvals.
- Prepared validation plans, remediation plans and quality system assessments.
- Responsible for the qualification of PLC based systems, Distributed Control Systems (DCS), various manufacturing, packaging, laboratory equipment, utilities and facilities.
Mr. Khatami has a B. S. Degree in Civil Engineering from the University of Massachusetts.
Sr. Director of Business Development
Michael has over 25 years of experience in the commissioning and qualification of equipment, utilities and facilities associated with pharmaceuticals (including aseptic processing), biotechnology and cosmetic industries. He has also managed large projects where he has developed project schedules and managed up to 25 people to complete their assigned tasks and meet the project timelines. In addition, he has been the SME for several FDA investigations and EMA investigations over the years for the equipment that he has qualified or the production teams that he has supervised.
Michael’s current role with VTS Consultants is to oversee project deliverables with our current clients and develop new relations with our potential clients. He is utilizing his experience in the industry to help our clients determine the best approach to meet their qualification and compliance needs. His experience provides our clients with the assurance that their needs will be met through a realistic approach and one that assure compliance and quality related deliverables.