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:
Take Back to Your Job: After completing this course, you will be able to:
Attendance is Suggested For: