The course provides an overview of the general principles of managing a quality organization, including methods to evaluate the organization, benchmarking, and the leadership role of the manager. This course also aims to improve effective communication between an organization's staff and quality assurance teams. Specific topics covered include similarities and differences among means of implementing and enforcing regulation, such as current Good Manufacturing Practice, (cGMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Total Quality Management (TQM), ISO 9001:2000, and Six Sigma quality guidelines for laboratory documentation; standard operating procedures (SOP); reporting, record keeping, and management; preparation and requirements for audits and inspections.Prerequisite: none.
Prior to Fall 2009, this course was titled Practical Laboratory Management.
