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

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