Quality Assurance is critical to the success of product development and manufacture and the maintenance of regulatory compliance. This course is designed to provide participants with extended knowledge of Quality Management, Quality Assurance and Quality Control and to highlight the challenges associated with QA in the pharmaceutical field. In this course, it clarifies the roles and expectations of Quality Assurance throughout the entire process, from development through audits and inspections. Students will gain a wide range of knowledge of quality assurance guidance: GMPs, GLPs, ICH, GDPs, how to write SOPs, do an investigation, product complaints, product recall, returned goods, change control and CAPA.