Why should you attend:
This webinar will provide the attendees with a better understanding of the current audit techniques used by the FDA and how they have changed over the years. In addition, areas of increased regulatory scrutiny will also be discussed such as data integrity issues. Additionally, the webinar will provide an overview that companies can use to evaluate their own state of compliance by knowing what have been the most common cited GMP deficiencies over the last year.
Areas Covered in the Session:
- Changes in FDA audit approaches
- Most common cited GMP drug deficiencies for 2012-2014
- Increase in FDA enforcement actions
- How best to address FDA 483 observations.
Who will benefit:
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.