BSCI 1211 Regulatory Compliance
An introduction to the basic concepts of federal regulation of bioscience/ biotechnology research and biomanufacturing. The structure and purview of the U.S. Food and Drug Administration U.S. Department of Agriculture Environmental Protection Agency and Occupation Safety and Health Administration will be covered. This course will also focus on the regulation of product produced in the life science sector including strategic planning compliance validation and documentation of production. Students will gain an understanding of the role of regulatory affairs in the overall business scheme. Differences between the regulatory requirements of the U.S. market compared to the European and Asian markets will be examined.