FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

A successful audit is dependent on understanding what we could expect from regulators. This can be observed by looking at the focus of recent inspections within the industry. Such case studies will help companies to analyze their own practice and address similar issues in advance. This ensures we will be better prepared for an FDA audit resulting in fewer errors. Furthermore, audit techniques used by the FDA has evolved over the years, anticipating what to expect helps to establish a more focused training program as part of the preparation. This 90 minute online session will focus on the changes in FDA Audit Practices and the current method used to determine audit frequencies by using a system of risk assessments. The word – “AUDIT” creates anxiety for the pharma, biotechnology and medical devices industry. This intensifies if you are unaware of how your company’s practices and procedures compare to the rest of the industry. Understanding the most valid regulations, the audit approaches used by regulators, and the common areas of industry deficiencies are part of getting through a successful regulatory inspection. In addressing all these key elements,

this webinar will:

  • Shed light on better understanding the current FDA Audit Practices and how they have changed over the years
  • Examine and analyze the top 10 common cited GMP drug manufacturing deficiencies over the last year
  • Scrutinize the significant increase in the number of warning letters issued over the last years
  • Review common areas of focus during audits
  • Provide a template that companies can use to evaluate their own state of compliance
  • Demonstrate examples to highlight various points discussed
Areas Covered in the Session :

  • Changes in FDA audit approaches
  • Areas of focus during audits
  • Most commonly cited drug GMP deficiencies for 2012-2013
  • Increase in FDA enforcement actions
  • Interactive Q&A Session
Who Should Attend:

  • Quality Assurance Teams
  • Quality Control Teams
  • Manufacturing Teams
  • Validation Teams
  • Production Teams
  • Regulatory Compliance Teams

FDB1967

Kenneth Christie

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, APIs 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.

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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
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