Preparing for FDA Medical Device Inspections – Practical Guidance
About This Course
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.
Key Learning Objectives
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
Who Should Attend
This course will benefit anyone involved in the preparation, hosting, and responding to FDA inspections.
Tutors
Sarah Moore - Sarah directs medical device and IVD consulting for NSF. She has more than 20 years of professional experience, including with quality management systems, regulatory compliance (U.S. FDA, Health Canada, EU MDD(R)/IVDD(R), U.S. EPA, CHINA NMPA), business mergers and acquisitions, continuous improvement, new product submission, product recall and remediation, risk management, process management, and people management. Both large and small international and culturally diverse companies have offered her a wide range of business experience over her career. Sarah believes people are the most critical resource that drives business, and she focuses her efforts and attention on building relationships first. When strong trust is built, healthy and profitable business always follows.