July 12 – 13, 2023
Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for the inspection. This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845), and practices used to plan, conduct, and assess inspections of medical device manufacturers.
Who should attend
This course benefits quality professionals responsible for managing, facilitating, and participating in 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 management system activity.