Regulatory Compliance, MS Quality Systems Specialization

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.

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.


Core Courses (6 units)

Course Title
MSRC 401-DLQuality Systems
MSRC 405-DLApplied Research and Writing
MSHA 409-DLStatistical Analysis
MSRC 435-DLRisk and Decision Management
MSRC 481-DLLeadership in the Regulatory Environment
MSRC 498-DLCapstone
or MSRC 590-0 Thesis Research

Specialization Courses (4 units)

Course Title
QARS 420-DLPractical Quality Management
QARS 421-DLApplied Quality & Regulatory Practices
QARS 425-DLQuality Assurance Project Management
QARS 450-DLMedical Device Regulations
or QARS 460-DL Drug and Biologics Regulations

Cross-Specialization Elective (1 unit)

Course Title
Choose one
Essentials of Initiating Clinical Research
Responsible Conduct of Research
Clinical Research Design & Methodology
Healthcare Regulatory Environment
Healthcare Programs and Enforcement
Healthcare Billing Models & Systems
IT Systems Compliance

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 course in which students integrate the knowledge they have gained in the core curriculum in work assigned 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.

Course Title
Choose one
Thesis Research