What to Expect and How to Manage An FDA Inspection

What to Expect and How to Manage An FDA Inspection


Are you fully prepared for FDA inspectors’ arrival? What questions will be asked? How should you respond?  Handling an FDA inspection can be nerve-wracking, even with an effective quality system. Attitude and other little things can also affect the inspection. This webinar will be a guideline to help prepare for an inspection, anticipate what FDA may be planning to do, and develop a procedure for handling FDA inspections.

Areas Covered in this webinar:

  • FDA Authority Background
  • Inspection Preparation
  • Do’s and Don’ts during an Inspection
  • Conduct of Inspections
  • Case Study-Warning Letter
  • Respond and Follow-up Activities

Who should attend:

This 90-min webinar will benefit those in the pharmaceutical, device and related industries, directly or indirectly involved in FDA inspections.

  • Executive Management
  • Regulatory Affairs
  • Quality Assurance and Control
  • Quality Auditors
  • Documentation Management
  • Manufacturing
  • Research and Development
  • Any personnel who want to learn about FDA Inspections

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