ComplianceOnline

Expert Profile


Kenneth Christie
Chief Operating Officer, VTS Consultants Inc

Kenneth Christie 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 Amhesrt, MA. His responsibilities specifically 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. He 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, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.

Trainings by Expert

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Category: Drugs and Chemicals (Pharma) , Medical Devices , Audit & Inspection , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , FDA Audit and Inspection , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , R & D , Laboratory , Contamination Control , Drug Development , Quality & Safety , Food & Dietary Supplements , Manufacturing & Contamination control , Drugs Regulations , Biotech Regulations , Audit & Inspection-Role , Food Safety Audit , All FDA Reg. based Audit , Medical Device Inspection , Lab Audit , Drugs Inspections , Documentation and Policy Management , Lifescience process & Procedures , Food Safety & Quality , Life sciences QA/QC , Research & Development , Drug R & D , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

The Regulatory Expectations for Environmental Monitoring Programs
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , Quality and Safety , QMS, ISO 13485, CAPA , Laboratory , Contamination Control , Microbiology Laboratory , Quality & Safety , Food & Dietary Supplements , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Current Regulatory Requirements for Sterile Products
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Contamination Control , Quality & Safety , Technologies and Processes , Blood and Blood Products , Tissue and Tissue Products , Cellular and Gene Therapy , Biologics and Biosimilars , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

Basic Requirements for IQ, OQ and PQ Protocols
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Quality & Safety , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Challenges of an Effective Change Control Program
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Quality & Safety , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Current Regulatory Requirements for Aseptically Produced Products
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Quality and Safety , Supply Chain and Manufacturing , Quality & Safety , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC