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The Graduate Certificate in Quality Assurance for Biomedical Products 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
- Online format provides flexibility for working professionals
- 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 for Drugs, Biologics, and Medical Devices
Experiential / Co-op opportunities
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.
Get Set with a Custom Course Plan
Complete a minimum of 8 quarter hours from the following:
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.
- 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.
Global Engagement Learn how our teaching and research benefit from a worldwide network of students, faculty, and industry partners.
Cost and Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2020-2021 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. For more detailed information, please visit Student Financial Services.
Our admissions process operates on a rolling basis; however, we do recommend following the application guidelines below to ensure you can begin during your desired start term.
|November 2, 2020||International out-of-country application complete (start date: January 19, 2021)|
|December 7, 2020||International in-country application complete (start date: January 19, 2021)|
|January 1, 2021||Domestic application complete (first half start: January 19, 2021)|
|February 12, 2021||Domestic application complete (second half start: February 22, 2021)|
|February 8, 2021||International out-of-country application complete (start date: April 12, 2021)|
|March 8, 2021||International in-country application complete (start date: April 12, 2021)|
|April 2, 2021||Domestic application complete (first half start: April 12, 2021)|
|May 14, 2021||Domestic application complete (second half start: May 24, 2021)|
|May 10, 2021||International out-of-country application complete (start date: July 12, 2021)|
|June 7, 2021||International in-country application complete (start date: July 12, 2021)|
|July 2, 2021||Domestic application complete (start date: July 12, 2021)|
|July 19, 2021||International out-of-country application complete (start date: September 20, 2021)|
|August 23, 2021||International in-country application complete (start date: September 20, 2021)|
|September 7, 2021||Domestic application complete (first half start: September 20, 2021)|
|October 18, 2021||Domestic application complete (second half start: November 1, 2021)|
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.
Where They Work
- Teva Pharmaceuticals
What They Do
- Quality Assurance
- Healthcare Services
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.
Career Opportunities and Services
Did You Know?
A graduate certificate can boost your earnings by an average of 25% (Washington Post, 2012).
Did You Know?
About 137,000 new regulatory affairs jobs were filled in 2018.
Did You Know?
68% of regulatory professionals pursue graduate studies.
Did You Know?
By enrolling in Northeastern, you gain access to our Global Network of more than 3,300+ corporate partners and 255,000 alumni.
From Our Faculty
"Experienced regulatory professionals are in demand. A graduate degree in regulatory affairs will help advance your career." — Professor Stephen Amato
From Our Alumni
"Northeastern's programs are led by skilled and experienced industry leaders who are committed to the engagement and growth of their students." — Stephen O'Halloran, '14