A UL course
This course was designed by the International Society for Professional Engineers (ISPE) and EduNeering, Inc. in cooperation with the US Food and Drug Administration (FDA) to help FDA inspectors recognize 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 the approach to inspecting these systems. Rather than covering medical device software in detail, the course goes over the inspection of systems that automate aspects of the medical device production process and/or quality systems.
- Use of computerized systems in the medical device industry
- How investigators should approach computerized systems
- Investigator reviews of computerized systems used in the medical device industry
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields