Curriculum for the Master's in Regulatory Compliance, Northwestern University School of Professional Studies - Northwestern School of Professional Studies

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.

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.

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 using health data. The MHA course is taught using RStudio statistical software.  A free online workshop in R is provided at https://sps.northwestern.edu/masters/resources.php#studio

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.

This course serves as an introduction to leadership theory, practice, and applications that guide leaders in regulated industries. The course will examine organizational leadership approaches and provide an opportunity for students to analyze case studies and real-world experiences. We will build from the basic premise that leadership and, more importantly, ethical leadership, is learned. Students will study leadership from an individual, organizational, and systemic level while applying learning to normative questions, as well as make sense and meaning in situations and context, and create a personal code of leadership ethics. 

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.

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.

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.

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.

This course provides a working knowledge of the compliance oversight of healthcare IT systems.  The focus of the course is on systems used in healthcare service provider settings. Topics  include identification of legal and regulatory computer system requirements used in the industry; ensuring system specifications and configurations meet regulatory requirements; setting criteria of system documentation to ensure compliance to inspectors; ensuring cyber security risks are mitigated; addressing European Union Privacy Laws for international systems; andiIdentifing 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, students will know how to build procedures to address any system violations consistently and thoroughly.

Healthcare Compliance track course.

This course is designed to provide an overview of the drug development process with an emphasis on the conduct of clinical trials. It will explore many facets of clinical trial conduct including regulatory, financial, operational, and ethical components. This course will view trial conduct from both the sponsor and site perspectives and students will gain a basic understanding of the complexities of clinical research and critically think about how to navigate them. Upon completion, students will have the knowledge and basic skills to pursue a position coordinating clinical trials at an investigative site or an operational position within a pharmaceutical company.

This course examines the primary regulatory and ethical requirements for researchers, research staff members, and institutions engaged in human, animal, and laboratory research. It encourages students to apply regulatory requirements to real-world settings. It includes various legal and ethical issues, and emphasizes the responsibilities of investigators and research staff within the research enterprise. The course challenges students to become critical thinkers and approach cases from a leadership perspective, considering how to integrate responsibility into organizational culture. It requires students to problem solve and draft remediation plans if needed.

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 have a knowledge of statistics before taking this course.

See Quality Systems courses below.

This course covers key quality management principles with some of the content based on the American Society for Quality (ASQ) Six Sigma Body of Knowledge, which includes topics such as Lean concepts, Design for Six Sigma (DFSS), and the Define, Measure, Analyze, Improve, Control (DMAIC) technique for process improvement. Upon completion of this course, you will be able to apply the quality management principles to lead quality departments, participate in or lead continuous improvement projects, and advance these concepts as part of any quality professional role in pursuit of compliance and business success. This course, along with the statistics core course requirement, can supplement the E-learning and Virtual or Face-to-Face Live certification preparation offered by ASQ to help prepare you for their Six Sigma Green Belt Certification Exam. Certification in this area can enhance career opportunities for quality professionals and individuals in other disciplines looking to employ these valuable tools and enable positive change. 

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

High quality and safe products are the output of robust design efforts and proper production and process controls. In a regulated environment, a manufacturer is required to have the proper facilities, equipment, monitoring programs, processes, and quality control testing in place to confirm the products being produced are safe and of high quality before they are released to market. This course explores quality standards and compliance regulations governing the manufacture and quality control testing of products with a focus on the laboratory setting. With an emphasis on the laboratory function, the course will walk through how controls are identified and implemented, including quality control testing in accordance with Good Manufacturing Practices (GMP). Elements that will be discussed include design control, risk management, equipment qualification and validation, out-of-specification results,  the CAPA (corrective action and preventive action) system, supplier controls, change control, and document control. By the end of the course, students will have demonstrated the ability to synthesize knowledge to create a comprehensive plan to control and test product quality.

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. Key concepts of leadership, talent management, and risk management will be integrated for successful project management. At the completion of this course, students will develop appropriate skills and competencies to lead and manage any projects in their organizations.

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.

Students in this quality systems course discuss current policies and guidelines under which pharmaceutical and biological 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.

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.