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Program Curriculum

Regulatory Compliance

Curriculum

Degree Requirements

Curriculum Overview 

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. 

Core courses (required):

MSRC 401 Quality Systems for Regulatory Compliance

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.

MSRC 405 Applied Research and 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.

MSRC 409 Biostatistics or MHI 409 Biostatistics

This course is designed for the biomedical researcher. Topics include descriptive statistics, hypothesis testing, estimation, t-tests, chi-squared tests, analysis of variance, linear regression, correlation, and nonparametric tests. Biomedical applications are discussed for each topic, as well as overall application of statistical methods in the informatics field.

MSRC 435 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.

LEADERS 481 Foundations of 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.

MSRC 498 Capstone course or MSRC 590 Thesis Research

MSRC 498 Capstone Project

The capstone project course is the culmination of the MSRC program and demonstrates to faculty a student's mastery of the curriculum and core competencies in the regulatory field. Assignments are chosen by the instructor. Students are individually assessed and graded throughout duration of the ten week class. Students should retain all course material from previous classes in the program, including textbooks, to successfully complete assignments.

Students may choose this course or registration in the 590 individual thesis research to fulfill their capstone requirement.

Prerequisite: Students may take one other course simultaneously with MSRC 498. All other course requirements must have been completed prior to the commencement of this course.

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.

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:

HC_COM 410 Healthcare Regulatory Environment

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.

HC_COM 411 Healthcare Compliance Programs

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. 

HC_COM 413 Healthcare Billing Models and Systems

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.

HC_COM 415 IT Systems Compliance or MHI 404 Health Care Enterprise Operations

This course provides a working knowledge of the compliance oversight of Healthcare IT Systems.  Focus for the course is on systems used in healthcare service providers. Topics include:  Identification of legal and regulatory computer system requirements used in the industry; Ensuring system specifications and configurations meet regulatory requirements; Set criteria of system documentation to ensure compliance to inspectors; Ensure cyber security risks are mitigated; Address European Union Privacy Laws for international systems; and Identify special considerations for Mobile Devices.  Upon completion of this course, students will have the ability to manage the compliance aspects of IT Systems throughout the system lifecycle (acquisition, upgrades and retirement).  In addition, they will know how to build procedures to address any system violations consistently and thoroughly.

Healthcare Compliance track course.

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

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.

CLIN RES 401 Responsible Conduct of Research

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. 

CLIN RES 403 Clinical Research Design and Methodology

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.

QARS 450 Medical Device Regulations or QARS 460 Drug & Biologics Regulations

See Quality Systems courses below.

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.

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.

QARS 420 Practical Quality Management

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.

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

QARS 421 Applied Quality and Regulatory Practices

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.

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

QARS 425 Quality Assurance Project Management

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.

QARS 450 Medical Device Regulations or QARS 460 Drug and Biologics Regulations

This course will provide an analysis of global medical device development and approval requirements, concentrating on the preparation of global medical device strategies. The course will cover the medical device classification and regulation by ministries of health around the world. FDA regulation of medical devices including Investigational Device Exemption (IDE), 510(k), and PMA will be taught as a foundation for looking at global regulatory submission pathways. In addition to FDA regulations, this course will cover medical device regulations for the European Union, Canada, and other major markets. Additionally, students will be exposed to common post-market challenges such as change control and import/export issues. Completing this course will position you to apply for first-tier regulatory professional job opportunities specific to medical devices, as well as new product development and managing products on the market from a regulatory perspective.

Quality Systems and Clinical Research track course.

QARS 460 Drug and Biologics Regulations

Students in this quality systems course discuss current policies and guidelines under which pharmaceutical, biological and medical device products are developed for human use and regulated while in commerce. Topics include regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, legal and ethical issues, and biological products. Students examine the newly implemented steps to harmonize international regulations. Students who complete this course will be prepared to research, identify and track the status of the regulations and guidance documents that impact the drug and/or biologics life cycle, as well as serving as valuable cross-functional team members representing regulatory affairs in a clinical operations setting.

Quality Systems and Clinical Research track course.

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.

MSRC 498 Capstone Project

The capstone project course is the culmination of the MSRC program and demonstrates to faculty a student's mastery of the curriculum and core competencies in the regulatory field. Assignments are chosen by the instructor. Students are individually assessed and graded throughout duration of the ten week class. Students should retain all course material from previous classes in the program, including textbooks, to successfully complete assignments.

Students may choose this course or registration in the 590 individual thesis research to fulfill their capstone requirement.

Prerequisite: Students may take one other course simultaneously with MSRC 498. All other course requirements must have been completed prior to the commencement of this course.

 

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