390 FDA Regulations for Medical Devices

This course provides an overview of the fundamental regulation for medical device manufacture. It focuses on the new FDA Quality System Regulation (previously called Good Manufacturing Practices). As FDA changes the regulations to meet international standards, including ISO-9000, a current awareness is critical to regulated businesses. The course includes coverage of the total quality system approach suggested by FDA, including preproduction quality assurance, manufacturing quality, the importance of feedback and management review, and the relationship

8 classes, 3 hr/class, evenings

Instructor: R. Keller