Mr. Kenneth J. Christie, Chief Operating Officer
Kenneth Christie joined VTS Consultants in 1998; he has 30+ years of sterile manufacturing and regulatory GMP consulting experience with Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. He oversees quality system auditing and GMP training and serves as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, and utilities and systems on a global basis. He also performs vendor audits and site pre-approval inspections and assists clients with addressing and correcting regulatory observations.
Kenneth was previously 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 and qualification activities. He routinely interacted 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.
A speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia, Kenneth is also a published author of articles dealing with the challenges of aseptic processing. Additionally, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
He has a Bachelor of Science degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State University.
Mr. Kayvan Khatami, Vice President of Operations
Kayvan Khatami joined VTS Consultants in 1995 and has over 20+ years of industry experience. He has been instrumental in leading VTS Consultants to its current position as one of the leading Validation and Compliance services in the United States and Puerto Rico.
During this time, Kayvan has consulted for a majority of the country’s premier pharmaceutical and biotechnology companies as well other companies and start-ups in the US and Puerto Rico. Kayvan’s achievements include:
• Managing 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.
• Validation plan preparation, 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.
Kayvan has a Bachelor of Science degree in Civil Engineering from the University of Massachusetts.