Applied Quality & Regulatory Practices

1 Unit · Graduate

Explores quality standards and compliance regulations governing the manufacture and quality control testing of products with a focus on the laboratory setting. Emphasis on the laboratory function, course covers how controls are identified and implemented, including quality control testing in accordance with Good Manufacturing Practices (GMP). Topics include design control, risk management, equipment qualification and validation, out-of-specification results, the CAPA (corrective action and preventive action) system, supplier controls, change control, and document control. By the end of the course, students will have demonstrated the ability to synthesize knowledge to create a comprehensive plan to control and test product quality.