Medical Device Manufacturing
An elective course in the Medical Device Development Certificate Program.
In this course, you will learn what manufacturing processes are typically used in medical product manufacturing, what the environmental aspects that need to be controlled, validations and process control expectations of regulatory bodies, as well as the aspects of product sterilization validation requirements. There will be an emphasis on the United States Food and Drug Administration perspective, thoughts, and expectations. Full analysis of examples and practical ‘how to’ recommendations and approaches is also presented. At the conclusion of the course, participants will be able to develop a full system approach to the manufacturing of a product of interest, and will be able to understand how to modify current Company systems to comply fully with all requirements. Class exercises help to emphasize the key aspects of the special needs for manufacturing and manufacturing controls in the medical product business sector.
