Speaker Profile


Kenneth Christie

BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

manufacturing and regulatory GMP consulting.

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 Amherst, MA. 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. 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 served 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.

Basic Requirements for IQ, OQ and PQ Protocols
Basic Requirements for IQ, OQ and PQ Protocols

Speaker:Kenneth Christie
Time: 20th October 2017 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90183

Fri
20
Oct 2017

Current Regulatory Requirements for Sterile Products
Current Regulatory Requirements for Sterile Products

Speaker:Kenneth Christie
Time: 5th December 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90455

Wed
05
Dec 2018

Recent FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies
Recent FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies

Speaker:Kenneth Christie
Time: 13th December 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90489

Thu
13
Dec 2018

The Regulatory Expectations for Environmental Monitoring Programs
The Regulatory Expectations for Environmental Monitoring Programs

Speaker:Kenneth Christie
Time: 29th November 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90472

Thu
29
Nov 2018

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