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Student from the quality assurance and regulatory science program at Mount St. Mary's University.

Quality Assurance and Regulatory Science Certificate

Lead quality control and regulatory compliance for your organization.

Mount St. Mary’s University is home to Maryland’s only certificate in quality assurance and regulatory science (QA/RS). The program prepares you to lead your company through the efficient delivery of high-quality products within a competitive market.

School of Natural Science and Mathematics

The graduate certificate in quality assurance and regulatory science is part of the School of Natural Science and Mathematics. Our goal as a department is to graduate women and men that are uniquely equipped to provide scientific perspective and solutions to the complex problems facing humanity.

Learn more
  • Undergraduate Major
  • Undergraduate Minor
  • Certificate
  • Graduate Program
  • Adult Undergraduate
  • Special Program

Graduate certificate designed for working adults.

You will gain valuable training and knowledge in areas of quality assurance, risk assessment, quality control and regulatory compliance from a global perspective. Courses include:

  • Quality Systems and Regulations
  • Biostatistics
  • International Regulation
  • Quality Management
  • Regulatory Compliance for Biologics and Drugs (elective) or Medical Devices and Combination Products (elective)

At the completion of the program, you will also be prepared to seek Lean Six Sigma Green Belt certification.

Program format

The QA/RS program is designed for working adults in biotechnology, biopharmaceutical or related industries. The Mount focuses on student success and emphasizes ethics and values.

  • Many students finish in less than a year. Five courses are offered in 8-week sessions, allowing you to focus on one class at a time and finish in less than one year.
  • Attend convenient classes. Most classes meet one night per week (6-9:30 p.m.) at our convenient Frederick campus, just minutes from I-70 and I-270.
  • Support from classmates and faculty. A low student-to-faculty ratio allows you to closely connect with your classmates and instructor.


$10,050 - Estimated total cost of tuition.* No additional fees.

  • Cost is based on 15 credits (five (5) courses) at $670 per credit.
  • No application fee.

Financial aid

Students may seek financial assistance through federal and state-funded programs, private loan providers, employer tuition remission or reimbursement, or deferment of undergraduate loans.

*Tuition represents 2019-20 rates, effective July 1, 2019. Tuition is subject to change without notice.

Admissions and application

  • Classes begin: Year-round.
  • Application evaluation: Year-round.
  • Application deadline: Four weeks prior to the start of the first course.
  • No application fee.

Applicants must have completed a bachelor's degree in science, engineering or a related field. A minimum undergraduate or graduate GPA of 2.75 is required or five full years of relevant work experience. A complete application includes:

  • Free online application.
  • Official transcripts from all schools attended after high school.
  • Résumé detailing professional experience
  • Additional requirements for international students may be required.

Gainful Employment Disclosure

While the majority of our students choose to earn a post-baccalaureate certificate in addition to a graduate degree, some opt for a stand-alone certificate program. For those opting to take only the certificate program additional information is provided and required by the federal government regarding program costs, financing, success rate and related occupations. See the Gainful Employment Disclosure information for the Quality Assurance and Regulatory Science Certificate Program.

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