Master of Science in Quality Assurance and Regulatory Science
QARS 401-0
( Core Course ) Regulation and Quality Systems
Introduction to the domestic and global regulatory landscape and essential quality systems governing Food and Drug Administration-regulated industries. Includes a review of the historical context for the creation of the FDA. A cross-industry overview for scientists charged with regulatory affairs and quality assurance responsibilities and of potential value to anyone with managerial duties affecting these areas. Discusses the pivotal role of quality in determining value chains and innovation; compliance with quality systems contained within the Code of Federal Regulations, International Organization for Standards, and International Conference on Harmonization. Prerequisite: none. This class may be taken as an elective for MCRRA.
