QT111: Preparing & Hosting Regulatory Inspections

Preparing and Hosting Regulatory Inspections

  • Learn how to host FDA or other regulatory inspection.
  • Make sure your personnel are trained on how to respond to the FDA – What to say, and how to say it!







Let Us Answer Your Questions About What to Expect When They’re Inspecting

  • Understand who is inspecting you.
  • Refuse them at your own risk!
  • There is no such thing as “passing” an FDA inspection!
  • There are varying degrees of GxP compliance that an organization can demonstrate during an inspection
  • "Co-manage" the Inspection.
  • Acting on Observations Made During the Inspection
  • Making a Good “Last” Impression
Be Prepared! ♦ Get Organized! ♦ Set the Tone!
All personnel in an organization should be trained on how to respond to the questions of an FDA Investigator.


Everything You Wanted To Know About Hosting a Regulatory Inspection Including:

  • What are the Fundamental Principles Guiding FDA Inspections Today
  • Legal and Regulatory Basis for FDA Inspections and Enforcement Activities - Statutes vs. Regulations vs. Guidelines
  • ORA’s Mission (Field Inspectors)
  • FDA’s Problems with Resources
  • What to Expect From an FDA Inspection – FDA Inspection Roadmap
  • How to Prepare For an FDA Inspection
  • How to Respond to FDA-483 Observations of Deficiency