This course has been designed by ISPE and EduNeering, Inc. in cooperation with the FDA/ORA, to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry.  The 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 inspection of systems that automate part of the device production process or part of the quality system.

Topics include:
      ·          How computerized systems are used in the medical device industry
      ·          How an investigator should approach computerized systems
      ·          The focus of the investigator’s review

Linda Belmont at DIA