What to Expect and How to Manage An FDA Inspection

What to Expect and How to Manage An FDA Inspection

$179.00

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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