Academic Program Proposal

Academic Program Proposal

Date
Proposal
Activated
Institution
and
Proposal
Degree
Awarded
Academic
Program
Name
Objections
Received
Decision
Deadline
MHEC Final
Action
Final
Decision
Date
4/19/2017Mount St. Mary's University
Proposal
PBCQualilty Assurance and Regulatory ScienceYes5/30/2017
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.pdfObjection from UM School of Pharmacy.pdf