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

Online 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 fully online program prepares you to lead your company through the efficient delivery of high-quality products within a competitive market.

Making it Easy for You

The Division of Continuing Studies strives to make it easy for you to go back to school on a part-time basis to help you advance your career. Online and evening classes delivered in an 8-week format allows you to move through your program quickly.

Our faculty and advisors work one-on-one with you to develop your degree plan, keep you on track, and ensure you gain knowledge you need to make a difference. It's important to us that you feel supported, can maintain your work-life balance, and have access to all of the resources you need to be a successful student. You will have all of the traditional college resources available to aid in your success, such as our award-winning Career Center, Writing Center, Library and Learning Services, just to name a few.

Start your free application

Coursework & Format

Become a leader in biotechnology development. Learn how to support product development and regulatory compliance through advanced training in 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)
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Virtual Open Houses

Learn more about the Division of Continuing Studies programs at our virtual open house series! Gain more information about our programs from our admissions team and program directors.

Register for an Upcoming Event

Designed to fit Your Life

The online 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.

  • 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.
  • Classes designed to support your life. All classes are offered fully online.
  • Support from classmates and faculty. A low student-to-faculty ratio allows you to closely connect with your classmates and instructor.

This program is available to be completed fully online asynchronous and/or synchronous.

Combine with a Master of Science in Biotechnology and Management

Want to expand your skills further? Consider the Mount’s Master of Science in Biotechnology and Management. Easily combine pursuit of a graduate degree with specialization in quality assurance and regulatory science. Learn more about the course sequence for combining the quality assurance and regulatory science post-baccalaureate certificate with the Master of Science in Biotechnology and Management degree.

See the Sequence

Want to see a full listing of all quality assurance and regulatory science certificate courses?

See full course listings

Affordability & Financial Aid

Graduate level programs are designed to be taken one course at a time, providing you the flexibility you need to complete the classes at your own pace; with that the program pricing is set by credit hours instead of by the year like traditional undergraduate programs.

  • 2023-24 tuition rates effective July 1, 2023 - $10,500 – Estimated total cost of program tuition.* No additional fees. Cost is based on 15 credits (five (5) classes) at $700 per credit.
  • 2024-25 tuition rates effective July 1, 2024 - $10,650 – Estimated total cost of program tuition.* No additional fees. Cost is based on 15 credits (five (5) classes) at $710 per credit.
  • No application fee.

*Tuition is subject to change without notice. Learn more about tuition and fees.

Financial Aid

Students enrolled on at least half-time basis (5-credits per semester) may qualify for financial aid. You may seek financial assistance through federal and state-funded programs, private loan providers, or deferment of undergraduate loans. The Mount also has a variety of employer tuition remission or reimbursement agreements with local businesses and community colleges, so you may just get a discount from your employer or previous college. Visit our Graduate Student Financial Aid webpage for more details.

Not sure if you qualify for financial aid? Learn more from our financial aid office.


Admissions & Application

Classes for the certificate begin at various times of the year including January, March, May, July, August and October, so submitting your application four weeks before your expected start date ensures a priority application decision. There is no application fee.

  • Application Deadline: Two weeks prior to the session start date.
  • Classes Begin: January, March, May, July, August and October.
  • Priority Application Deadline: Four weeks prior to the start of the first course.
  • No application fee.

Program Admission Requirements

Applicants must have completed a bachelor's degree. 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.

Free Application

Graduate Science Programs 301-682-8315

Free Application