FDA Inspection Readiness Training

Virtual Learning

April 27 – 28, 2022

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 Objectives
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)

Course Tutor
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.
Price: $1200.00