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Graduate Certificate in Regulatory Compliance at Northwestern University

Northwestern University, United States

Programme overview

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.

Faculty: School of Professional Studies  |  Duration: 4 courses  |  Study mode: part-time  |  Intake: Fall, winter, spring and summer quarters  |  Location: Evanston, IL, United States

What you will study

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

Official programme page

Application information

Entry requirements

Applicants hold a U.S. bachelor's degree from a regionally accredited institution or foreign equivalent. Application: online application, 300-550 word statement of purpose, resume, one letter of recommendation, official transcripts; some certificates also require a writing sample. Applications are accepted each quarter (deadlines July 15, October 15, January 15, April 15).

Intake: Fall, winter, spring and summer quarters

Duration: 4 courses

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