This online course has been designed to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. This course explains how computerized systems are used in the medical device manufacturing process and provides an approach to inspecting these systems. This course does not cover the detailed review of software that forms part of a medical device; it covers only the inspection of computerized systems that automate part of the device production process or part of the quality system. Before taking this course, users should complete Requirements for Computerized Systems Validation and Compliance and Approach to Computerized Systems Validation and Compliance.
The Compliance Program (CP) guidance manual Inspection of Medical Device Manufacturers (CP7382.845) provides guidance to FDA field and center staffs for the inspection of medical device firms. This Compliance Program provides for an inspectional strategy designed to result in more efficient, focused, and harmonized (with the international community) quality system inspections.
This inspectional strategy, called the Quality System Inspections Technique (QSIT), is based on a “top-down” inspection of a manufacturer’s quality system, using the seven subsystems of the Quality System regulation — Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), Production and Process Controls (P&PC), Facilities and Equipment Controls, Material Controls, and Records/ Documents/Change Controls. This course addresses the following:
- 21CFR Part 820—Quality System Regulation
- Compliance Program Guidance Manual: Inspection of Medical Device Manufacturers (CP7382.845)
- General Principles of Software Validation
- GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems (ISPE, 2008)
- Quality Management System • Process Validation, Edition 2
- Glossary of Computerized System and Software Development Terminology
- CP 300.100 Inspection of Manufacturers of Device Components
Take Back to Your Job: After completing this course, you will be able to:
- Recognize where computerized systems are used in the medical device manufacturing process, recognize FDA's approach to inspecting computerized systems, and identify the levels of review that may be used and what comprises each level.
Attendance is Suggested For:
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
- Computer system vendors or consultants, engineering contractors, and validation service companies.