Send us your interest if this course is currently not offered or the current schedule does not accomodate your schedule. It is often necessary to understand interest a semester in advance for planning and scheduling. Companies and organizations can often request a course if the group is large enough. This doesn't mean that we can make accommodations in every case. However, we will utilize and maximize our available resources as best as we can. Thanks for letting us know your interests and we will respond as soon as we can.
This course will instruct students in the principles, requirements and expectations of the U.S. FDA application of current Good Manufacturing Practices (cGMPS) to medical device production. Included in the course contents will be regulatory definition of what constitutes a medical device, the divisions of FDA that oversee medical device applications and compliance, as well how the regulatory risk-based categorization of medical devices effects the scope of cGMPS applied to various types of medical device products.