Master of Science in Regulatory Compliance, Northwestern University School of Continuing Studies

Program Overview:

Regulatory Compliance

Regulatory compliance is increasingly visible in healthcare, life science and clinical research arenas. An interdisciplinary professional program, Northwestern University’s part-time MSRC program addresses core areas of regulatory compliance, including risk management, quality systems, leadership and communication skills. The MSRC curriculum focuses on these interdisciplinary core competencies while also stressing practical applications within the program’s three tracks: healthcare compliance, clinical research and quality systems. Graduates are prepared to assume leadership positions in healthcare compliance, clinical research compliance or quality systems in the life sciences. This breadth of course offerings sets our program apart, as does our partnership with the Northwestern University Feinberg School of Medicine. This affiliation informs the curriculum with the latest insights on healthcare, translational research and regulation.

Inside MSRC

Karriem S. Watson, MS, MPH
Instructor in the MS in Regulatory Compliance Program and co-founder and co-president of AcaMED Clinical Research Associates. Watson is also a research manager in the neurosurgery department of a major teaching hospital. He also researches community engagement in clinical trials and protocol design, execution and recruitment.

Program Goals

Utilize regulatory, risk management and quality systems to assure compliant healthcare, clinical research and pharmaceutical environments.
Interpret regulatory requirements and apply them to various roles in healthcare, clinical research and pharmaceutical industries.
Create systems and processes to assure compliant quality outcomes.

Program Tracks

Upon admission to the program, students choose one of the following tracks, designed to help effectively develop industry expertise in the these areas:

Curriculum Requirements

The Master of Science in Regulatory Compliance requires completion of 11 courses—four core courses, four track (elective) courses, one cross-elective track course, a leadership course and a capstone project (590). View curriculum details for this program.

Core Courses:

LEADERS 481-0 Leadership
The purpose of this course is to identify the fundamental leadership behaviors that enable people to excel in their careers, and to help students apply these behaviors to personal and professional success. The course builds from the basic premise that leadership is learned and looks at the theory and practice of leadership at the individual and organizational level. The course will explore definitions of leadership, the importance of leadership, leadership styles, the role of vision and integrity, the importance of giving and receiving feedback, how to lead change and solve problems, effective teamwork, and communication strategies. The culmination of the class will be a personal leadership development plan formulated by each student.

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MSRC 401-0 Quality Systems

Introduction to essential quality systems and the domestic and global regulatory landscape governing regulated industries. Includes a review of the historical context for the creation of the organizations that protect public health, including the Department of Health and Human Services and the Food and Drug Administration. A cross-industry overview for anyone charged with regulatory affairs and quality assurance responsibilities as well as those with managerial duties affecting these areas. Discusses the pivotal role of quality in determining value chains and innovation; compliance with quality systems contained within the Code of Federal Regulations (GxP and DHHS regulations), Malcolm Baldrige National Quality Award, International Organization for Standards (ISO 9000:2001), Total Quality Management, and International Conference on Harmonization, FDA Quality System Inspection Technique (QSIT) National Committee for Quality Assurance (NCQA) and The Joint Commission for Accreditation of Healthcare Systems.

Previously titled QARS 401Regulation and Quality Systems. Core requirement for MSRC and MQARS; may be taken as an elective for MCRRA.

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MSRC 405-0 Research & Writing

This course provides a foundation for writing academic and technical papers, affording students the opportunity to recognize and address the strengths and weaknesses in their own critical thinking and writing skills. The course emphasizes logical argument development, structure, clarity of thinking, and effective use of documentation Students learn to evaluate the strengths and limitations of various research methods and how to select the best method for a given task.

Previously titled QARS 405. Core course for MSRC, MQARS, and MCRRA.

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MSRC 409-0 Biostatistics

This course is an introduction to biostatistics. Students learn to apply statistical techniques to the processing and interpretation of data from health studies. Topics covered include probability, descriptive statistics, study design, and linear regression, among others.

Previously titled CLIN_RES 409, this course is a core course for MSRC, MQARS and MCRRA.

Students may substitute MED INF 409-DL Introduction to Biostatistics instead of MSRC 409-0.

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MSRC 435-0 Risk and Decision Management

This course explores theories and practical applications of risk management, risk communication, decision management, and crisis management in life science industries. Topics include failure modes and effects analysis; fault-tree analysis; human factors analysis, and hazard analysis and critical control points. Students learn to anticipate and avoid risk and hazards and manage those that arise in a holistic manner.

Previously titled QARS 435. Core course for MSRC and MQARS students.

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MSRC 590-0 Thesis Research

This final project is meant to represent the culmination of students’ experience in the program and must demonstrate mastery of the curriculum and ability to conduct sustained independent research and analysis. The project may be applied or may be a traditional scholarly paper, in both cases a write-up following the paper’s program-specific guidelines is required. Students must submit a proposal and secure a first reader in order to register; for further details students are advised to review the student handbook and contact their academic advisor.

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Regulatory Compliance

Inside MSRC

Program Goals

Program Tracks

Curriculum Requirements

Core Courses:

Elective Courses:

Regulatory Compliance

Graduate Options

Northwestern University SCHOOL OF CONTINUING STUDIES

Regulatory Compliance

Inside MSRC

MSRC at Northwestern University

Patient Success Stories in Clinical Research

What Makes MSRC Unique?

Program Goals

Program Tracks

Curriculum Requirements

Core Courses:

Elective Courses:

Regulatory Compliance

Graduate Options