Beyond Borders: Navigating FDA Inspections for Medical Devices Globally - EP 2
🔍 Unraveling the FDA's 2-approach inspection method! 🕵️♂️
Discover how FDA inspectors gather information and evidence with two distinct approaches. 🧐
1️⃣ "Top Down" Approach: Evaluate the quality system as a whole, focusing on key subsystems like Corrective and Preventive Actions, Design Controls, and Production & Process Controls. This approach ensures compliance with regulatory requirements and effectiveness in implementation.
2️⃣ "Bottom Up" Approach: Start with specific quality problems, like non-conforming device reports, and trace back through company procedures. This method assesses actions taken in response to issues.
Get insights into these approaches for FDA inspections! Watch Ep. 2 now. 📽️🔒