Regulatory Compliance

Curriculum and Program Tracks

The Master's in Regulatory Compliance requires the completion of 11 courses. This covers four core courses, four courses corresponding to a declared program track, one cross-elective track course, one leadership course and a capstone (498) or thesis (590) project. Program tracks allow students to tailor their studies to specific career goals. Current students should refer to curriculum requirements in place at time of entry into the program. 

Healthcare Compliance Track Courses

Gain a strong grounding in healthcare laws and regulations and learn the basics of healthcare billing and payment and corporate compliance. Graduates of the Healthcare Compliance specialization are able to employ their compliance knowledge at both a systems and discrete level. For example, they will be able to assess and manage compliance programs; develop compliance dashboards and conduct and respond to audits; and screen and evaluate vendors.

  • HC_COM 410 Healthcare Regulatory Environment
  • HC_COM 411 Healthcare Compliance Programs
  • HC_COM 412 Healthcare Regulatory Enforcement
  • HC_COM 413 Healthcare Billing Models and Systems 

ACCREDITATION


MSRC is a CCB (Compliance Certification Board) accredited program for students in the healthcare compliance specialization. HC specialization students who complete the degree are exempt from the work-experience eligibility requirement and can sit for all seven of the healthcare compliance and general industry compliance and ethics exams:

  • Certified in Healthcare Compliance (CHC)
  • Certified in Healthcare Research Compliance (CHRC)
  • Certified in Healthcare Privacy Compliance (CHPC)
  • Certified in Healthcare Compliance Fellowship (CHC-F)CCB logo
  • Certified Compliance and Ethics Professional (CCEP)
  • Certified Compliance and Ethics Professional-International (CCEP-I)
  • Certified Compliance and Ethics Professional Fellowship (CCEP-F)

Certification helps demonstrate your expertise in mitigating compliance-related risks, addressing legal obligations, and promoting organizational integrity in your industry.  

Clinical Research Track Courses

Students specializing in clinical research are given a solid framework from which to understand clinical research.  A graduate’s understanding of clinical study design, drug development and regulatory requirements allows them to manage many facets of the clinical research endeavor, whether developing and implementing clinical research protocols or overseeing GCP, compliance and financial matters at an individual or multi-site level.

  • CLIN RES 400 Essentials of Initiating Clinical Research
  • CLIN RES 401 Responsible Conduct of Research
  • CLIN RES 402 Drug and Device Development or QARS 450 Medical Device Regulations or QARS 460 Drug and Biologics Regulation
  • CLIN RES 403 Clinical Research Design and Methodology 

Quality Systems Track Courses

Rapid technological advances and increased globalization have spurred government and industry regulations. The changing environment has transformed job and performance expectations for chemists, scientists, technicians, and managers. The quality systems specialization is designed for students to explore concepts and problems in quality assurance and regulatory affairs that span life science industries, thus encouraging a cross-pollination of best practices and systems.

  • QARS 420 Practical Quality Management
  • QARS 421 Applied Quality and Regulatory Practices
  • QARS 425 Quality Assurance Project Management
  • QARS 450 Medical Device Regulations or QARS 460 Drug and Biologics Regulations

Quality Systems specialization students will have the knowledge they need to sit for the ASQ Six Sigma Green Belt certification exam after completing the degree. ASQ certification increases the potential for a higher salary and demonstrates proficiency in the quality and regulatory science fields.

About the Final Project

Students pursue their capstone experience independently or as part of a team. As their final course, students take either the individual research project in an independent study format or the classroom final project class in which students integrate the knowledge they have gained in the core curriculum in a project presented by the instructor. In both cases, students are guided by faculty in exploring the body of knowledge on regulatory compliance while contributing research of practical value to the field. The capstone independent project and capstone class project count as one unit of credit.

  • MSRC 498 Capstone Project or
  • MSRC 590 Thesis Research