QAC

Graduate Certificate in Quality Assurance Compliance-Online

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.

Take a quick look

We’re committed to creating an education as unique as your career path. So, whether your goal is a new career or moving up in your field, our innovative programs will get you going your way.

01

Customize your plan

We work with you to map your path to your goal.

02

Learn from experience

From real-world case studies to employer-based projects, we prepare you to manage what comes next.

03

Choose your focus

Whatever you’re passionate about, you’ll find the classes to sharpen your specialty.

04

Study anywhere, on your time

Part-time or full-time, we move at your speed, to get you where you’re going.

Enrollment

Part-Time

Entry Terms

Fall, Spring, Summer, Winter

Completion Time

6-12 months

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

  • 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

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.

Learn About Getting Real World Experience

Get Set with a Custom Course Plan

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.

Global Engagement Learn how our teaching and research benefit from a worldwide network of students, faculty, and industry partners.

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

Application Deadlines

Fall 2021

Recommended Admissions Deadline:
Domestic application complete (first half start: September 20, 2021) September 7, 2021
Domestic application complete (second half start: November 1, 2021) October 18, 2021

Winter 2022

Recommended Admissions Deadline:
Domestic application complete (first half start: January 10, 2022) December 20, 2021
Domestic application complete (second half start: February 22, 2022) February 8, 2022

Spring 2022

Recommended Admissions Deadline:
Domestic application complete (first half start: April 11, 2022) March 28, 2022
Domestic application complete (second half start: May 23, 2022) May 9, 2022

Summer 2022

Recommended Admissions Deadline:
Domestic application complete (first half start: July 11, 2022) June 27, 2022
Domestic application complete (second half start: August 8, 2022) July 25, 2022

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

    • 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)

 

Learn more about Northeastern Alumni on Linkedin.