Preparing for FDA Medical Device Inspections – Practical Guidance

Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection. This instructor-led two-day course was developed by a career FDA field investigator and CDRH compliance officer, and is designed to provide insight into FDA inspectional resources including CP 7382.845 and the Quality System Inspection Technique (QSIT). In addition, through comprehensive breakout group exercises, learners will demonstrate an understanding of:

• the various types of medical device inspections conducted by FDA
• best practices for preparing for and hosting an inspection
• utilizing FDA databases (MAUDE, Recall) to prepare for routine and For Cause inspections
• utilizing 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 the investigator will need to prepare an FDA Establishment Report.

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 through practical exercises concepts learned

This course will benefit anyone involved in the preparation, hosting, and responding to FDA inspections.

Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

Nanci Dexter - Nanci has over 35 years of experience in the medical device and IVD industries. Nanci has created numerous quality systems for small and medium-sized companies, conducted mock FDA and ISO13485 audits and authored many worldwide regulatory submissions. Her diverse experience ranges from auditing, leading compliance remediation projects, conducting regulatory strategies and holding regulatory and quality management positions in both the United States and Europe.