FDA Inspection Readiness Training - Updated for 2022 - Brought to you by Compliance Architects LLC

FDA Inspection Readiness Training. Presented by FDA-regulated industry veterans Teresa Gorecki and Jack Garvey of Compliance Architects LLC. Updated for 2022 Chapters: 00:00:00 - Introduction and Background 00:08:53 - Types of FDA Inspections 00:18:30 - Understanding FDA Inspections and Enforcement Actions 00:28:26 - Components of a Quality System 00:38:06 - The Two Kinds of Changes: Planned and Unplanned 00:47:40 - How to Prepare for an FDA Inspection 00:56:47 - Conducting Honest Inspections 01:06:13 - The Importance of Transparency and Honesty 01:15:33 - FDA Compliance and Response: Best Practices 01:25:35 - Conclusion and gratitude