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Program Overview

Regulatory Compliance

Master's in Regulatory Compliance

Regulatory compliance is increasingly visible in healthcare, life science and clinical research arenas. As a result, career opportunities in regulatory compliance are multiplying for those with the kind of training students receive in the Master of Science in Regulatory Compliance (MSRC) program. An interdisciplinary professional program, Northwestern University’s part-time MSRC program addresses core areas of compliance, including risk management, quality and regulatory science, practices and enforcement, leadership and communication skills. The MSRC curriculum focuses on these core competencies while also stressing practical applications within the program’s three tracks: healthcare compliance, clinical research and quality and regulatory science. MSRC graduates are prepared to assume leadership positions in healthcare compliance, clinical compliance, and in quality and regulatory industries, including pharmaceutical, life sciences, food, and medical device industries. Even PhDs can significantly enhance their skill sets and find new professional opportunities in this increasingly important and sensitive field.

The program offers a thorough grounding in the interdisciplinary core competencies of regulatory compliance, including risk management, quality and regulatory science, leadership and communication skills. MSRC places a strong emphasis on practical application: courses are taught by industry experts — leading minds with extensive experience in navigating regulatory compliance challenges. MSRC’s partnership with Northwestern Memorial Hospital, the Northwestern University Feinberg School of Medicine and the Northwestern University Clinical and Translational Science Institute is another benefit, continuously feeding the program with the latest insights on healthcare, translational research and regulation.

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Brynnan Foster

The program helped me to hit the ground running when I accepted my current position. There’s almost no responsibility I have now that I didn't first encounter in the MSRC program.”

Brynnan Foster (MSRC '11) clinical research specialist at Fresenius Kabi

CLINICAL AND TRANSLATIONAL SCIENCE AWARD RECOGNITION 

The MSRC program was presented at the Clinical and Translational Science Award (CTSA) Consortium Steering Committee (CCSC) in December, 2013. The MSRC degree program abstract, Training the Clinical and Translational Workforce of Tomorrow, was selected from abstracts submitted by all sixty CTSAs nationally as one of eleven to be orally presented at the 2013 national meeting held in Washington, DC. The MSRC program successfully meeting one of the primary goals of the CTSA, to increase the skills of the clinical and translational research workforce and provide them with career pathways to retain them in industry and academia.

About the MS in Regulatory Compliance

Master's in Regulatory Compliance Program Goals

An interdisciplinary professional program, MSRC graduates will possess the knowledge, skills and aptitude to:

  • 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.

Regulatory Compliance Curriculum & Program Tracks

The Regulatory Compliance Curriculum requires completion of 11 courses—four core courses, four track (elective) courses, one cross-elective track course, a leadership course and a capstone (498) or thesis (590) project. 

Upon admission to the program, students choose one of the following Regulatory Compliance Program Tracks, designed to effectively develop industry expertise in these areas:

  • Clinical Research
  • Quality Systems
  • Healthcare Compliance (Compliance Certification Board accredited)

 

MS in Regulatory Compliance Courses

Explore MS in Regulatory Compliance Courses. You can narrow your course search by day, location or instructor.

Master's in Regulatory Compliance Admission

A variety of factors are considered when your application is reviewed. Applicants must hold a bachelor’s degree from a regionally accredited institution or its foreign equivalent. A competitive undergraduate record that indicates strong academic ability is required. Work or research experience in a related field is highly desirable but not a requirement for admission. The Graduate Record Examination (GRE) is not required, but strong scores bolster chances for admission. For a complete list of requirements, see the Master's in Regulatory Compliance Admission page.

Regulatory Compliance Tuition and Financial Aid

Tuition for the Master's in Regulatory Compliance program at Northwestern is comparable to similar US programs. Financial aid opportunities exist for students at Northwestern. Complete details can be found on the Regulatory Compliance Tuition and Financial Aid page.

Registration Information for Regulatory Compliance

Already accepted into the Master's in Regulatory Compliance program? Get ahead and register for your classes as soon as possible to ensure maximum efficiency in your trajectory.

Mentorship, Internships & Careers in Regulatory Compliance

MSRC students can access industry and healthcare system mentors who support and guide their professional development, as well as professional internships in regulatory compliance, healthcare compliance, quality systems, and clinical research that enhance their career and academic goals. Find out more about Mentorship, Internships & Careers in Regulatory Compliance.

Regulatory Compliance Faculty

Instructors in the Master's in Regulatory Compliance program at Northwestern are leaders in the field. They bring practical real-world experiences to the online classroom and engage with students on an interpersonal level. Get to know the instructors on the Regulatory Compliance Faculty page. 


Find out more about Northwestern's M.S. in Regulatory Compliance

Core Courses:Course Detail
Leadership <> LEADERS 481-0

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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Leadership <> LEADERS 481-DL

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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Quality Systems for Regulatory Compliance <> MSRC 401-0

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.



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Quality Systems for Regulatory Compliance <> MSRC 401-DL

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.


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Applied Research & Writing <> MSRC 405-0

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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Introduction to Biostatistics <> MSRC 409-0

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.Students will do homework using SPSS, a statistical software package. SPSS is installed in some Northwestern computer labs and can be rented (downloaded to your personal computer) from https://estore.onthehub.com. The Graduate Pack 23 is sufficient for class.

This course is a core course for MSRC, MQARS and MCRRA.

Students may substitute MED INF 409-DL Biostatistics (now titled MHI 409-DL).


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Risk and Decision Management <> MSRC 435-0 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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Risk and Decision Management <> MSRC 435-DL

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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Thesis Research <> MSRC 590-0

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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Elective Courses:Course Detail
Essentials of Initiating Clinical Research <> CLIN_RES 400-0

This course provides a comprehensive analysis of the fundamental concepts and activities in the clinical research process. Emphasis is on practical application of guidelines that govern clinical research guidelines from sponsor and site perspectives and best practices for clinical trial conduct, monitoring and financial management. Topics include legal and ethical issues.

Clinical Research track course. Core course for MCRRA, elective for MQARS students.

 


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Responsible Conduct of Research <> CLIN_RES 401-0

This course examines the primary regulatory and ethical requirements for researchers, research staff members and institutions engaged in human, animal and laboratory research. It includes various legal and ethical issues, and emphasizes the responsibilities of investigators and research staff within the research enterprise.

Clinical Research track course. Core course for MCRRA, elective for MQARS students.

 


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Clinical Research Design and Methodology <> CLIN_RES 403-0

This course explores the application of research design and methodology theories and concepts to the practical conduct of a clinical trial. Topics include commonly used research designs, methods for randomization and blinding, data collection methods (including electronic data capture) and implications of design and methodology for clinical trial operations from study initiation to data lock. It is recommended that students take MSRC 409 or MED INF 409 Biostatistics before this course.

Clinical Research track course. Core course for MCRRA, elective for MQARS students.

 


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Healthcare Regulatory Environment <> HC_COM 410-0

This course facilitates an in-depth exploration of the healthcare laws, regulations, statutes, policy guidance and enforcement initiatives that serve as a framework for healthcare compliance. Topics include but are not limited to legal and ethical issues, patient safety, patient privacy and security, coding and billing, conflict of interest, anti-kickback, and False Claims.

Healthcare Compliance track course.


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Healthcare Regulatory Environment <> HC_COM 410-DL

This course facilitates an in-depth exploration of the healthcare laws, regulations, statutes, policy guidance and enforcement initiatives that serve as a framework for healthcare compliance. Topics include but are not limited to legal and ethical issues, patient safety, patient privacy and security, coding and billing, conflict of interest, anti-kickback, and False Claims.

Healthcare Compliance track course.


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HC Programs & Enforcement <> HC_COM 411-0

This course provides a comprehensive overview of health care compliance programs, including each of the seven core elements and strategies for developing, implementing and managing effective compliance programs in a heavily regulated environment. The course describes compliance healthcare enforcement authorities, such as Medicare and Medicaid auditors (e.g., Recovery Auditors, UPIC’s) and current key healthcare fraud initiatives. Topics also include the basics of conducting risk assessments, audits and investigations. Previous title: Healthcare Compliance Programs.

Healthcare Compliance track course.

 


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Healthcare Billing Models and Systems <> HC_COM 413-0

This course provides a basic understanding of billing and payment structure for healthcare services in the U.S. and systems that promote compliance with federal and state laws, audits, and communications with government and other parties. Topics include: national coverage decisions and local coverage decisions, patients, service providers and payors, billing and coding for services, impact of medical necessity, credentialing and authorization processes, and coding.

Healthcare Compliance track course.

 


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Practical Quality Management <> QARS 420-0

This course is based on the six-sigma Body of Knowledge (BOK) and is designed, along with the statistics core course requirement, to prepare students to pass the ASQ's Green Belt Exam. Topics include an overview of Six Sigma, Lean principals, design for Six Simga and the DMIAC technique for process creation and improvement.

Quality Systems track course. Core course for MQARS, elective for MCRRA students.

Prior to Fall 2009, this course was titled Practical Laboratory Management.

It is highly recommended that students complete MSRC 401 and biostatistics prior to taking this course.


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Applied Quality and Regulatory Practices <> QARS 421-0

This course explores quality, standards, and compliance regulations in the laboratory, as well as a review of the laboratory system components that support compliance with quality system regulations and science-based laboratory management. Includes the following specific topics: managing a quality system within an analytical laboratory environment; laboratory certification and accreditation; calibration, qualification, and maintenance of laboratory equipment, review of facility requirements; study of laboratory deviations, failure investigations, and compliance with out-of-specification requirements (CAPA); test method development, system suitability, and method verification and validation; installation qualification, operational qualification, and performance qualification protocols; notebooks and maintenance logs; training staff and tracking training.

Quality Systems track course. Core course for MQARS, elective for MCRRA students.

It is highly recommended that students complete biostatistics prior to taking this course.


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Quality Assurance Project Management <> QARS 425-0

Students will gain and apply skills in developing and leading projects that create value in any area, but with specific focus on improving quality, service, and regulatory compliance. They will be able to apply critical thinking to their projects and determine which tools to use from a broad array of proven methodologies. They will review current research in effective project management. A review of Total Quality Management (TQM), Malcolm Baldrige Criteria, and ISO Quality Management Systems will be performed to ensure that projects can deliver results that create the highest value by supporting the overall objectives of a quality/regulatory organization. Microsoft Project 2010 software will be used to create the team-based project. .

Quality Systems track course. Elective for MQARS and MCRRA students.

 


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Medical Device Regulations QARS 450-0

Analysis of U.S. medical-device development and approval requirements, including regulatory reforms implemented under the Food and Drug Modernization Act, Clinical Laboratory Improvement Amendments, the Center for Devices and Radiological Health reengineering initiatives, and evolving Investigational Device Exemptions; pre-market Approval; 510(k) application process; product development protocol development and review processes. The course also explores emerging developments and trends in medical-device regulation in the United States. Topics include legal and ethical issues. .

Quality Systems and Clinical Research track course. Elective for MQARS and MCRRA students.

 


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