Graduate Certificate in Quality Assurance Compliance - Boston

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

Boston, MA

Location

Part-Time

Commitment

6-12 months

Duration of Program

Fall, Spring, Summer, Winter

Entry Terms

Yes

Meets F1 Visa Requirements

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Overview

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

In this program, students will have the opportunity to achieve the following learning outcomes:

Describe the general standards utilized by the United States Food and Drug Administration (FDA) and other global regulatory agencies to evaluate the safety and efficacy of existing and new biomedical products utilized by healthcare practitioners in the U.S. market
Demonstrate proficiency in the application of compliance-associated regulations and standards for global biomedical products throughout their life cycle
Differentiate between the distinct stages of the global biomedical product commercialization process from regulatory and standards-based compliance perspectives
Detail the fundamental regulatory compliance and standards-based processes under which biomedical products must be manufactured in order to maintain the level of safety and efficacy upon which they were approved for marketing by FDA and other global regulatory agencies

Unique Features

Choose from elective courses that cover a broad range of practical and relevant issues in the field
The BTC 4450 Quality Control and Validation Issues course was developed in collaboration with quality assurance professionals from Vertex Pharmaceuticals and other external pharmaceutical industry partners
Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs

Admissions

A graduate degree or certificate from Northeastern—a top-ranked university—can accelerate your career through rigorous academic coursework and hands-on professional experience in the area of your interest. Apply now—and take your career to the next level.

Program Costs

$14K

Tuition

Finance Your Education We offer a variety of resources, including scholarships and assistantships.

How to Apply Learn more about the application process and requirements.

Requirements

Online application
Statement of purpose (500–1000 words): Identify your educational goals and expectations of the program. Please be aware that Northeastern University's academic policy on plagiarism applies to your statement of purpose.
Professional resumé
Unofficial undergraduate transcripts; official transcripts required at the time of admission
Two letters of recommendation from individuals who have either academic or professional knowledge of your capabilities such as a faculty member, colleague, or mentor, preferably one from your current employer
English language proficiency proof. Students for whom English is not their primary language must submit one of the following:
- Official associate or bachelor's degree transcript from an accredited college or university in the U.S., stating degree conferral and date
- TOEFL, IELTS, PTE, Duolingo, or NU Global Exam scores

Are You an International Student? Find out what additional documents are required to apply.

Admissions Details Learn more about the College of Professional Studies admissions process, policies, and required materials.

Admissions Dates

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.

Curriculum

Industry-aligned courses for in-demand careers.

For 100+ years, we’ve designed our programs with one thing in mind—your success. Explore the current program requirements and course descriptions, all designed to meet today’s industry needs and must-have skills.

Experiential Learning

Northeastern's signature experience-powered learning model has been at the heart of the university for more than a century. It combines world-class academics with professional practice, allowing you to acquire relevant, real-world skills you can immediately put into action in your current workplace. This makes a Northeastern education a dynamic, transformative experience, giving you countless opportunities to grow as a professional and person.

Learn About Getting Real World Experience

Faculty

Our Faculty

Northeastern University faculty represents a broad cross-section of professional practices and fields, including finance, education, biomedical science, management, and the U.S. military. They serve as mentors and advisors and collaborate alongside you to solve the most pressing global challenges facing established and emerging markets.

Students

By enrolling in Northeastern, you’ll gain access to students at 13 campus locations, 300,000+ alumni, and 3,000 employer partners worldwide. Our global university system provides students unique opportunities to think locally and act globally while serving as a platform for scaling ideas, talent, and solutions.

Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.

Where They Work
- Shire
- Pfizer
- Medtronic
- Biogen
- Teva Pharmaceuticals
What They Do
- Legal
- Research
- Quality Assurance
- Operations
- Healthcare Services
What They're Skilled At
- Regulatory Affairs
- Pharmaceutical Industry
- U.S. Food and Drug Administration
- Clinical Trials
- Standard Operating Procedure (SOP)