U.S. FDA Medical Device Inspections: What to Expect

Understanding what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare. NSF’s FDA medical device inspections course helps domestic and foreign medical device manufacturers doing business or intending to do business in the United States.

This course focuses on identifying and understanding the FDA’s inspection criteria, resources (including key standard operating procedures such as CP 7382.845) and practices used to plan and conduct inspections of medical device manufacturers.

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

• Identify key requirements of the FDA’s Quality System (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803) Regulations
• Recognize the intent of regulatory requirements as described in preamble discussions
• Recognize key similarities and differences between 21 CFR Part 820 and ISO 13486:2016
• Identify inspectional resources used by FDA investigators
• Identify key elements/focus of FDA’s Quality System Inspection Technique (QSIT)

This course benefits quality professionals responsible for managing and facilitating FDA inspections, as well as those responsible for defining, documenting, implementing and maintaining an effective quality management system.

This course is important for medical device professionals, especially those who conduct or participate in any project and/or quality systems activities.

Course tutors can include:

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.