Managing FDA Inspections: Implementing Effective Strategies

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FDA and other regulatory inspections are an inevitable part of working within the pharmaceutical industry.  FDA inspections can be very resource and time intensive and, if an organization is not prepared, the FDA inspection can lead to serious consequences for an organization.  This webinar will discuss strategies for preparing and managing an FDA regulatory inspection at your facility.  The webinar will focus on planning, preparation, and training of personnel that may be involved in hosting or supporting an FDA inspection.


Part I – Planning for a Regulatory Inspection

  • Organizational readiness and planning
  • Procedure for hosting an FDA inspection
  • Internal audits and mock inspections


Part 2 – Hosting the FDA Inspection

  • Arrival of the FDA Investigator
  • Notification to Management
  • FDA Inspection Room Logistics
  • The “War Room”


Part 3 – The Inspection 

  • Managing the Facility Tour
  • Responses to FDA Inquiries and documentation requests
  • Request for review of electronic records
  • Follow-up activities, including daily summaries


Part 4 – The Close Out and Responses to FDA-483s

  • Inspection Close Out Meeting
  • Immediate Actions
  • Responding to the FDA-483


Takeaway Tools

  • FDA Inspection SOP


Top Reasons to Attend:

  1. Understand how to plan for FDA inspections
  2. Inspection readiness considerations
  3. Managing the FDA inspection
  4. Facilitating the Close-out meeting and responses


Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

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Chris Wubbolt

Principal, QACV

Chris Wubbolt is a Certified Six Sigma Black Belt, has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. Mr. Wubbolt was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.