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Quality Assurance and Regulatory Science Program Announced

Communications Staff

Recognizing the employment needs of the robust biotechnology and biopharmaceutical industries in the region, Mount St. Mary’s University will offer a quality assurance and regulatory science (QA/RS) graduate certificate program beginning in July 2018 at its conveniently located Frederick, Maryland campus.

qars-announcement-300.jpegThe QA/RS graduate certificate program – the only one in Maryland – will prepare employees to lead their company through the efficient delivery of high-quality products within a competitive market. The program is designed for scientists and other professionals in biotechnology, biopharmaceuticals and related industries who are seeking advanced training and knowledge in the areas of quality assurance, risk assessment, quality control and regulatory compliance from a global perspective.

“We’re excited to offer this certificate program to benefit the Maryland-Northern Virginia biotechnology hub,” said Dean of Graduate, Continuing and Professional Studies Carol Rinkoff. “This concentrated program of five eight-week courses will allow students to certify that they have gained focused expertise in less than a year.”

By 2024, Maryland is expected to need 11 percent more quality inspectors and 16 percent more compliance officers, according to the Maryland Department of Labor, Licensing and Regulation. Classes in the certificate program, offered one evening per week in accelerated sessions, include biostatistics, quality systems and regulations, international regulations, quality management, and an elective course (regulatory compliance for biologics and drugs or regulatory compliance for medical devices and combination products). Biostatistics, the first course in the sequence, will be taught by Assistant Professor Susan Mertins, Ph.D., a former senior investigator at the National Cancer Institute.

“Quality assurance is the hallmark of the biotech and biopharmaceutical industries. Through the certificate program, employees can develop and demonstrate expertise that meet career goals in a short period of time,” explained Concetta E. Dudley, Ph.D., director of Graduate Programs in Science at Mount St. Mary’s. Students who complete the certificate program will be prepared to seek Lean Six Sigma Green Belt certification, Dudley said.

The QA/RS program joins the Master of Biotechnology and Management as the second graduate program in science at The Mount. The two programs are among more than 20 graduate and adult programs designed for working adults hosted at the Frederick campus.

For more information about or to apply to the QA/RS certificate program, visit our QARS program page

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Communications Staff