Graduate Certificate in Regulatory Compliance

Students enrolled in the Regulatory Compliance certificate have the flexibility in their course selection to explore different aspects of healthcare regulation, leading to a more informed choice of specialization when transferring to the master’s program (MSRC). They may select four courses offered in the master’s program curriculum in the areas of clinical research, healthcare compliance, and quality systems. Students can concentrate on course work that supports preparation for the ASQ (American Society for Quality) certifications, for example, refresh their knowledge of the regulatory requirements of clinical research studies, and acquire foundational knowledge needed in all aspects of the healthcare regulatory industry.





Complete this four-course certificate and apply your credit to the MS in Regulatory Compliance program at SPS.


About the Regulatory Compliance Certificate

Graduate Certificate in Regulatory Compliance Learning Outcomes

After successful completion of the Regulatory Compliance certificate, students will be able to:

  • Utilize regulatory, risk management and quality systems to assure compliant clinical research, laboratory, or patient care environments.
  • Interpret regulatory requirements and apply them to various roles in different life sciences industries.
  • Create systems and processes to assure compliant quality outcomes.

Regulatory Compliance Curriculum

Complete the following four courses to earn the certificate: 

  • MSRC 401 Quality Systems for Regulatory Compliance
  • Any three courses among the following core and elective courses: 
    • MSRC 405 Applied Research and Writing
    • MSRC 409 Biostatistics or MHA Statistical Analysis
    • MSRC 435 Risk and Decision Management
    • MSRC 481 Leadership in the Regulatory Environment
    • CLIN RES 400 Essentials of Initiating Clinical Research
    • CLIN RES 401 Responsible Conduct of Research
    • CLIN RES 403 Clinical Research Design and Methodology
    • HC_COM 410 Healthcare Regulatory Environment
    • HC_COM 411 Healthcare Programs and Enforcement
    • HC_COM 413 Healthcare Billing Models and Systems
    • HC_COM 415 IT Systems Compliance
    • QARS 420 Practical Quality Management
    • QARS 421 Applied Quality and Regulatory Practices
    • QARS 425 Quality Assurance Project Management
    • QARS 450 Medical Device Regulations
    • QARS 460 Drug and Biologics Regulations

Review curriculum details while you consider applying to this program. Current students should refer to the curriculum requirements in place at time of entry into the program.

Regulatory Compliance Course Schedule

The Regulatory Compliance Course Schedule page provides you with detailed information on the program's offerings.

Regulatory Compliance Faculty

You can find a full listing of our instructors in this certificate program on the Regulatory Compliance Faculty page.

Admission for the Regulatory Compliance Certificate

A variety of factors are considered when your application is reviewed. Background and experience vary from student to student. For a complete list of requirements, see the Graduate Certificate Admission page.

Regulatory Compliance Tuition

Tuition costs can vary for each of our programs. For the most up-to-date information on financial obligations, please visit our Regulatory Compliance Tuition page.

Regulatory Compliance Registration Information

The Graduate Certificate Registration Information page outlines important dates and deadlines as well as the process for adding and dropping courses.

Find out more about Northwestern's Regulatory Compliance Certificate

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