Program Courses
Please note that course schedules may be amended due to low enrollment, faculty availability, and/or other factors.
Online Sync Sessions are an integral part of the online learning experience. Additional information about learning concepts and assignments may be discussed and sync sessions offer valuable opportunities for students to interact with their faculty and peers during the term. We encourage all students to attend live, but if they are unable to, sync sessions will be recorded and posted within Canvas to allow for an asynchronous model of success as well.
MSRC 401-DL : Quality Systems for Regulatory Compliance
Description
Introduction to essential quality systems and the domestic and global regulatory landscape governing regulated industries. Includes a review of the historical context for the creation of the organizations that protect public health, including the Department of Health and Human Services and the Food and Drug Administration. A cross-industry overview for anyone charged with regulatory affairs and quality assurance responsibilities as well as those with managerial duties affecting these areas. Discusses the pivotal role of quality in determining value chains and innovation; compliance with quality systems contained within the Code of Federal Regulations (GxP and DHHS regulations), Malcolm Baldrige National Quality Award, International Organization for Standards (ISO 9000:2001), Total Quality Management, and International Conference on Harmonization, FDA Quality System Inspection Technique (QSIT) National Committee for Quality Assurance (NCQA) and The Joint Commission for Accreditation of Healthcare Systems.