Academic Program Proposal

Date Proposal Activated	Institution and Proposal	Degree Awarded	Academic Program Name	Objections Received	Objection Deadline
4/19/2017	Mount St. Mary's University Proposal	PBC	Qualilty Assurance and Regulatory Science	Yes	5/30/2017
Qualilty Assurance and Regulatory Science Program Description
The graduate certificate (PBC) in Quality Assurance and Regulatory Science is designed for biotechnology and biopharmaceutical professional who are seeking advanced knowledge and training in the area of quality assurance, quality control, regulatory affairs, and risk assessment. The curriculum will provide graduates with the knowledge and skills needed to improve process and product performance, enhance the quality and reliability of goods and services, and implement steps to make their organizations more efficient. Candidates for admission into the QA/RS program must have completed a bachelor’s degree in a science, engineering, or related field, meet minimum grade point average requirements, and have five full years of relevant, professional experience. The proposed graduate certificate program has been tailored to meet the needs of biotechnology and biopharmaceutical companies utilizing coursework on-line, on-site, and hybrid modes of learning. Completion of the program will provide students with an understanding of applicable FDA standards and processes, and international regulations, Good Manufacturing Practices and supporting GxP standards; a working knowledge of quality systems and quality management; industry and regulatory standards; and a foundation for ethical decision making.
Objection(s) to Proposal and Response(s) Listed Below
Objection from UM School of Pharmacy.pdf