Good Laboratory Practices and in-vitro Toxicity Testing

Tech-at-Bench-3Designed to cover the FDA’s current Good Laboratory Practice (CGLP) regulations and how they affect the conduct of non-clinical laboratory safety studies, this course introduces the various elements of cGLP as described in 21 CFR 58. ¬†Topics include, but are not limited to, a discussion of the requirements for the study director, quality assurance unit, personnel and testing facility management, testing facility operations, test and control articles, equipment, study protocol and implementation, documentation and archival of records and materials.¬† In addition, the history of and modern approaches to safety testing including in-vitro toxicity testing methodologies will be reviewed.