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.
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Customize your plan
We work with you to map your path to your goal.
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From real-world case studies to employer-based projects, we prepare you to manage what comes next.
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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
Get Set With a Custom Course Plan
Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.
General Requirements
Complete one of the following:
| 2.00 | ||
| 2.00 | ||
| 3.00 |
Complete the following courses:
| 4.00 | ||
| 4.00 | ||
| 2.00 |
Choose from the following to reach 16 quarter hours:
| 4.00 | ||
| 4.00 | ||
| 3.00 |
Now Let's Talk Admissions
You know where you are headed and you've seen how our program will lead you there. So let's get going. Here's what you need to know before you enroll.
Application 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
International Requirements
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.
Financing Requirements
Finance Your Education We offer a variety of resources, including scholarships and assistantships.
How to Apply Learn more about the application process and requirements.
Cost and Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2024-2025 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.
Application Deadlines
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.
Student Body Profile
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.
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Where They Work
- Shire
- Pfizer
- Medtronic
- Biogen
- Teva Pharmaceuticals
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What They Do
- Legal
- Research
- Quality Assurance
- Operations
- Healthcare Services
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What They're Skilled At
- Regulatory Affairs
- Pharmaceutical Industry
- U.S. Food and Drug Administration
- Clinical Trials
- Standard Operating Procedure (SOP)
Learn more about Northeastern Alumni on Linkedin.