Regulations and Quality Management

Catalog description

A course designed for science professionals to develop and apply skills and knowledge for managing business operations. Real-world business cases are used to develop students' management capacity and capability. Areas of focus include the process view of organizations, performance measures, products and product attributes, production processes, process competencies, procurement and supply chain management and regulatory requirements. The laws and regulations enforced by the Food and Drug Administration and other regulatory agencies related to the biotechnology, pharmaceutical, and medical device industries are surveyed. Included is the U.S. legal regulatory system, Food, Drug, and Cosmetic Act and related laws, Freedom of Information Act, regulation affecting foods, drugs, biologics, veterinary products, diagnostics, and devices, FDA enforcement, product liability, and import/export requirements. Reviews the impact of quality systems and the functions, roles, and responsibilities on Quality Assurance and Quality Control.