Biography

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. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations. He 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. He 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 has served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

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Research Interest

The research interest presentation will review current and past audit approaches by the FDA, the four types of inspections performed, the regulatory forms associated with all FDA audits, what data sources are used by the FDA in preparing for their audits, common areas of focus, issues associated with data integrity, five proposed categories of “operator error” that are looked at when revieiwing investigations that cite operator error as the probable cause and the top 10 most common cited drug GMP deficiencies for the last three years (2012-2014).