FDA Inspection Readiness Training

Virtual Learning

September 15 – 16, 2021

Course Overview

Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for an FDA inspection. This 16 hour course is designed to meet the needs of domestic and foreign medical device manufacturers doing business or intending to do business in the United States. This course focuses on identifying and understanding 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. This course is designed to benefit your organization’s 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.

Learning Objective

At the end of this course, students will be able to:
· Identify key requirements of FDA’s Quality System (21 CFR Part
820) and Medical Device Reporting (21 CFR Part 803) Regulations

· Recognize the intent regarding 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)