FDA Inspection Readiness Training - Updated for 2022 - Brought to you by Compliance Architects LLC
Автор: Compliance Architects LLC
Загружено: 2021-03-02
Просмотров: 2243
Описание:
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
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