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

Duration: 90 Minutes
In preparing for a regulatory audit, two very important sources of information to seek include knowing what the auditors will look for as areas of focus and what have been the most commonly cited drug GMP deficiencies. These items will help companies to better evaluate their own practices, address similar deficiencies that may have been found during internal audits and to prioritize their efforts so as to make sure they do not become another statistic of the top 10 most drug cited GMP deficiencies for 2012-2013.
GMP Manufacturing
Instructor: Kenneth Christie
Product ID: 500239

Why Should you Attend:
By knowing the audit techniques and current areas of focus used by auditors, this webinar will help companies in their preparation and training of applicable personnel as to how best to get through the audit. The most common cited GMP deficiencies for drugs will be reviewed to provide a template against which companies can evaluate their own state of compliance and to correct those areas where similar deficiencies are noted. Preparation is the key to passing any audit and the information to be discussed in this webinar is an excellent resource to use.

Objectives of the Presentation:
This webinar will provide attendees an overview of current audit approaches used by regulatory inspectors and the opportunity to see what has been the most commonly cited GMP deficiencies. This information can be used as a training tool for such audits and a template for helping to assure a state of compliance.

Who can Benefit:
  • Production
  • Quality Assurance
  • Quality Control
  • Regulatory
  • Vendors
  • Engineering
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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, medical devices and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Prior to joining VTS, Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility in Rochester, MI. While there, he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. Additional responsibilities included 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.
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