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 introduces students to 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 laboratory notebook maintenance, an introduction to current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), development of meaningful Standard Operating Procedures, Code of Federal Regulations for Electronic Recordkeeping (21 CFR Part 11 compliance), and documentation or recordkeeping basics in a regulated industry. Upon completion, students should be able to demonstrate knowledge of the importance of creating a documentation and quality system capable of reproducing an accepted or approved procedure. Course components include a quality systems overview, the FDA, quality assurance, team building, current good manufacturing practices (cGMP), validation, project management for a start-up company, environmental monitoring, documentation and recordkeeping.