Quality Management

1 Course Unit

Quality management encompassing quality assurance and the controls necessary across people, processes, and technology plays a critical role in the reliability and reproducibility of product development for the life science industry. As a key component of the Quality Management System (QMS), quality assurance (QA) includes all activities performed by an organization for the prevention of errors and defects. This course intends to focus on quality principles, elements of the quality system, standards and requirements as applicable to the FDA-regulated product development lifecycle. Further, the course aims to offer examples of risk based quality management approaches, quality control (QC) measures, and oversight as an aspect of inspection readiness. Application of an integrated quality management program and the interfaces between Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GVP) regulated activities during clinical development will also be addressed. Fall 1 Course Unit