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 emphasizes the regulatory requirements for implementing and maintaining a quality system to facilitate the production of a product in a safe and consistent manner. Topics include an in-depth overview of cGMP, cGLP, and International Organization for Standardization (ISO) regulations as they relate to biomanufacturing, a brief exploration of risk analysis in the quality system, and procedures for regulatory audits. Upon completion, students will demonstrate an understanding of the importance for maintaining a quality system and the effects that this system has on the successful launch of products to market and the overall success of a company. Course components include FDA background information, definitions, the FDA process, FDA regulations, and audits.