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College of Professional Studies

Quality Assurance Compliance

Certificate

The Graduate Certificate in Quality Assurance Compliance provides in-depth knowledge of global regulatory and compliance requirements for the development, marketing approval, and clinical utilization of biomedical products.

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Program Format
On ground
Time Commitment
Part Time
Duration
6 - 12 Months
Entry Term(s)
Fall, Spring, Summer, Winter
Meets F1 visa requirements
Yes

Program overview

Excel in QA compliance

The Graduate Certificate in Quality Assurance Compliance prepares you to navigate the compliance aspects of industry-specific regulatory standards throughout their product life cycle.

In this program, you’ll dive into global regulatory standards and their application, understand the biomedical product commercialization process, and learn about the fundamental processes under which biomedical products must be manufactured. Upon graduation, you’ll be well-equipped to advance your career in today’s dynamic global health environment.

Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs.

F-1 students must be full-time students during their first term and can take a reduced course load in their final academic term, as long as there are no other degree requirements. Students are not eligible for OPT, as they have not completed one academic year (two quarters having been completed rather than the three quarters that is the academic year).

Choose from elective courses that cover a broad range of practical and relevant issues in the field. Several courses were developed in collaboration with our quality assurance business partners.

Admissions

Apply to the program

A graduate degree or certificate from Northeastern can accelerate your career through rigorous academic coursework and real-world professional experience in your area of interest. Apply to take your career to the next level.

Our admissions process operates on a rolling basis; however, we do recommend the application guidelines below to ensure you can begin during your desired start term:

Domestic Application Guidelines

International Application Guidelines*

*International deadlines are only applicable if the program is F1 compliant.


  • Online application

  • Professional resumé

  • Unofficial, personal copies of transcripts from all colleges and universities attended; official transcripts are required at the time of enrollment

    • The Foreign Credential Evaluation (FCE) is a required assessment of all transcripts and documents. Please review the FCE requirements by country.

  • English language proficiency proof

  • Please refer to the CPS Apply Now page to learn about additional materials that may be required

Program objectives

Prepare for success

In this program, you’ll gain practical, in-demand quality assurance skills that can set you apart when applying to jobs within the industry.

Understand regulatory standards

Describe the standards utilized by the U.S. Food and Drug Administration (FDA) and other global regulatory agencies to evaluate the safety and efficacy of existing and new biomedical products in the U.S. market.

Apply your skills

Demonstrate proficiency in the application of compliance-associated regulations and standards for global biomedical products throughout their life cycle.

Learn essential processes

Differentiate between the distinct stages of the global biomedical product commercialization process from regulatory and standards-based compliance perspectives.

Articulate manufacturing processes

Detail the regulatory compliance and standards-based processes under which biomedical products must be manufactured to maintain the level of safety and efficacy upon which they were approved for marketing.

Connect with us

Want more information?

We’re here to answer your questions about this program, the application process, and more. Complete the form below to receive additional program details and speak with a member of our enrollment team. 

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Degree building

Stack your certificate

Earning a graduate certificate is a fast and affordable way to acquire specialized skills while building toward your master’s degree. Upon completion of this certificate program, you may be able to apply your credits to an eligible master’s program, saving time and money on your degree.

Some of the eligible master’s programs for this certificate include:

Contact an enrollment counselor to learn more about eligibility requirements.

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Cost of attendance

Tuition and financial aid

  • $15,120
    Tuition in USD

Estimated Total Tuition

This is an estimate based on the tuition rates for Academic Year 2025-2026 and does not include any fees or other expenses. Some courses and labs have tuition rates that may increase or decrease total tuition. Tuition and fees are subject to revision by the president and Board of Trustees at any time. Select programs at select campuses offer additional scholarships of up to 25% off the listed price for domestic students studying on campus. For more detailed information, please visit Student Financial Services.

For students interested in pursuing financial assistance or educational loans, additional educational costs, known as Cost of Attendance (COA) components, can be included in the calculation of aid and loan eligibility. Components may include food, housing, books, course materials, supplies, equipment, transportation, personal expenses, and the cost of obtaining a first professional licensure. You can find comprehensive details on the Student Financial Services website. Please keep in mind that COA can vary significantly depending on academic program, enrollment intensity, and individual circumstances.

There are many ways to pay for your education, including scholarships, financial aid, and more. Connect with a financial counselor to learn about your options and make your dream a reality.

Visit tuition & financial aid
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