Preparing for FDA Medical Device Inspections - Practical Guidance

Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare. This instructor-led two-day course was developed by a career FDA field investigator and CDRH compliance officer, and provides insight into FDA inspectional resources including CP 7382.845 and the Quality System Inspection Technique (QSIT).

Through breakout group exercises, learners will develop an understanding of:

• The various types of medical device inspections conducted by FDA
• Best practices for preparing for and hosting an inspection
• Using FDA databases (MAUDE, Recall) to prepare for routine and For Cause inspections
• Using the preamble to 21 CFR Part 820 to understand FDA inspectional objectives
• Preparing FDA 483 responses
• The types of FDA Establishment Reports and how to proactively assemble the information investigators need

On completion of this FDA medical device inspections course, you will be able to:

• Identify inspectional guidance resources used by FDA investigators
• Identify key elements of FDA’s Quality System Inspection Technique (QSIT)
• Identify the types of FDA inspections and the focus of each
• Recognize good inspection preparation and hosting practices
• Recognize how to effectively respond to FDA 483 observations
• Demonstrate concepts learned through practical exercises

Tutor

This training will be delivered by one of our experts –  click here to learn more .