Pharmaceutical Quality Control and Quality Assurance

This course addresses the roles and responsibilities associated with Quality Assurance and Quality Control as they relate to the Canadian and North American Pharmaceutical industry. The critical components that make up a pharmaceutical quality system will be discussed including documentation, auditing, risk assessment, deviation management, change control, complaint handling, method validation, corrective action and preventative action, equipment and computer system validation processes, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), product recall, and document review. Case studies will be used where appropriate for students to learn and practice their skills.