Program Overview

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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.

Curriculum

Core Courses (6 units)

• MSRC 401-DL: Quality Systems
• MSRC 405-DL: Applied Research and Writing
• MSHA 409-DL: Statistical Analysis
• MSRC 435-DL: Risk and Decision Management
• MSRC 481-DL: Leadership in the Regulatory Environment
• MSRC 498-DL: Capstone or MSRC 590-0: Thesis Research

Specialization Courses (4 units)

• QARS 420-DL: Practical Quality Management
• QARS 421-DL: Applied Quality & Regulatory Practices
• QARS 425-DL: Quality Assurance Project Management
• QARS 450-DL: Medical Device Regulations or QARS 460-DL: Drug and Biologics Regulations

Cross-Specialization Elective (1 unit)

• Choose one:
  • CLIN_RES 400-DL: Essentials of Initiating Clinical Research
  • CLIN_RES 401-DL: Responsible Conduct of Research
  • CLIN_RES 403-DL: Clinical Research Design & Methodology

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.

• Choose one:
  • MSRC 498-DL: Capstone
  • MSRC 590-0: Thesis Research

Northwestern University

Northwestern University offers various programs through its different schools, including the School of Professional Studies, The Graduate School, and undergraduate programs.

School of Professional Studies

The School of Professional Studies offers graduate programs, including:

• Data Science
• Global Health
• Health Analytics
• Healthcare Administration
• Health Informatics
• Information Design and Strategy
• Information Systems
• Liberal Studies
• Literature
• Prose and Poetry
• Public Policy and Administration
• Regulatory Compliance
  • Regulatory Compliance, MS
  • Regulatory Compliance, MS Clinical Research Specialization
  • Regulatory Compliance, MS Quality Systems Specialization
• Sports Administration
• Writing

The Graduate School

The Graduate School offers various programs, including:

• Academic Policies and Procedures
• Programs A-Z
• Courses A-Z
• Program Statistics

Undergraduate Programs

Northwestern University offers undergraduate programs through its various schools, including:

• Henry and Leigh Bienen School of Music
• School of Communication
• School of Education and Social Policy
• Robert R. McCormick School of Engineering and Applied Science
• Medill School of Journalism, Media, Integrated Marketing Communications
• Judd A. and Marjorie Weinberg College of Arts and Sciences

Each school offers a range of programs, including majors, minors, and certificates. The university also offers dual graduate and undergraduate degrees, dual bachelor's degrees, and study outside Northwestern opportunities.

Academic Calendar

The academic calendar is available on the university's website.

Academic Integrity

The university has a policy on academic integrity, which is available on its website.

Academic Support

The university offers various academic support services, including tutoring and advising.

Additional Baccalaureate Options

The university offers additional baccalaureate options, including:

• Accelerated Bachelors
• Certificates
  • Kellogg Certificates
  • McCormick Certificates
  • Medill Certificates
  • Programs & Centers Certificates
• Minors
  • Bienen Minors
  • Programs & Centers Minors
  • SoC Minors
  • McCormick Minors
  • WCAS Minors
• Second Majors
  • Bienen Second Majors
  • WCAS Second Majors

Dual Graduate & Undergraduate Degrees

The university offers dual graduate and undergraduate degrees, including:

• Honors Program in Medical Education
• Premedical Scholars Program

Dual Bachelor's Degrees

The university offers dual bachelor's degrees, including:

• BA/BS in Liberal Arts and Engineering
• BA/BMus in Liberal Arts and Music
• BA/BS or BS/BS in Communication and Engineering
• BA/BMus, BS/BMus, BA/BAMus, or BS/BAMus in Communication and Music
• BSED/BMus or BSED/BAMus in Education and Social Policy and in Music
• BS/BMus or BS/BAMus in Engineering and Music
• BSJ/BMus in Journalism and Music
• BSED/BSJ in Education and Social Policy and in Journalism

Study Outside Northwestern

The university offers study outside Northwestern opportunities.

Undergraduate Research

The university offers undergraduate research opportunities.

Special Programs & Courses

The university offers special programs and courses, including:

• College Transition Programs
• Innovation in News and Storytelling
• Military Programs
  • Naval Science

Academic Calendar

The academic calendar is available on the university's website.

Academic Integrity

The university has a policy on academic integrity, which is available on its website.

Academic Support

The university offers various academic support services, including tutoring and advising.

Henry and Leigh Bienen School of Music

The Henry and Leigh Bienen School of Music offers programs, including:

• Composition and Music Technology
  • Composition Major
  • Composition Minor
  • Music Technology Minor
• Conducting and Ensembles
• Jazz
  • Jazz Studies Major
• Music Cognition
• Music Core
• Music Education
  • Music Education Major
  • Music Education Minor
• Music Studies for Nonmajors
• Music Technology
• Music Theory and Cognition
  • Music Cognition Major
  • Music Cognition Minor
  • Music Theory Major
  • Music Theory Minor
• Musicology
  • Musicology Major
  • Musicology Minor
• Piano
  • Piano Major
• String Instruments
  • String Instruments Major
• Voice and Opera
  • Voice and Opera Major
• Winds and Percussion Instruments
  • Winds and Percussion Instruments Major

School of Communication

The School of Communication offers programs, including:

• Communication Sciences and Disorders
  • Human Communication Sciences Major
  • Human Communication Sciences Minor
• Communication Studies
  • Communication Studies Major
  • Management of Creative Industries Certificate
• Dance
• Human Communication Sciences
• Interdepartmental Communication Options
• Performance Studies
  • Performance Studies Major
  • Performance Studies Minor
• Radio/Television/Film
  • Film and Media Studies Minor
  • Game Design + Media Arts + Animation Minor
  • Radio/Television/Film Major
  • Sound Design Minor
• Theatre
  • Dance Major
  • Dance Minor
  • Music Theatre Certificate
  • Theatre Major
  • Theatre Minor

School of Education and Social Policy

The School of Education and Social Policy offers programs, including:

• Elementary Teaching
  • Elementary Teaching Major
• Human Development in Context
  • Human Development in Context Major
• Learning and Organizational Change
  • Learning and Organizational Change Major
• Learning Sciences
  • Learning Sciences Major
• Secondary Teaching
• Social Policy
  • Social Policy Major
• Experiential Learning
• Civic Engagement Certificate

Robert R. McCormick School of Engineering and Applied Science

The Robert R. McCormick School of Engineering and Applied Science offers programs, including:

• Applied Mathematics
• Architectural Engineering and Design
• Artificial Intelligence
  • Artificial Intelligence Minor
• Biomedical Engineering
  • Biomedical Engineering Degree
• Chemical Engineering
  • Chemical Engineering Degree
  • Biotechnology and Biochemical Engineering Minor
• Civil and Environmental Engineering
  • Civil Engineering Degree
  • Environmental Engineering Degree
  • Architectural Engineering and Design
  • Environmental Engineering Minor
• Computer Engineering
• Computer Science
  • Computer Science Degree
  • Computer Science Minor (McCormick School of Engineering)
• Curious Life Certificate
  • Curious Life Certificate
• Design Engineering (Engineering Design)
• Electrical and Computer Engineering
  • Computer Engineering Degree
  • Electrical Engineering Degree
• Engineering Sciences and Applied Mathematics
  • Applied Mathematics Degree
• Environmental Engineering
• Farley Center for Entrepreneurship
  • Entrepreneurship Minor
• General Engineering
• Human Computer Interaction
  • Human Computer Interaction Certificate
• Industrial Engineering and Management Sciences
  • Industrial Engineering Degree
• Machine Learning and Data Science
  • Machine Learning and Data Science Minor
• Materials Science and Engineering
  • Materials Science and Engineering Degree
• Mechanical Engineering
  • Mechanical Engineering Degree
• Segal Design Institute
  • Manufacturing and Design Engineering Degree
  • Segal Design Certificate
• Robotics

Medill School of Journalism, Media, Integrated Marketing Communications

The Medill School of Journalism, Media, Integrated Marketing Communications offers programs, including:

• Integrated Marketing Communications
  • Integrated Marketing Communications Certificate
• Journalism
  • Journalism Degree

Judd A. and Marjorie Weinberg College of Arts and Sciences

The Judd A. and Marjorie Weinberg College of Arts and Sciences offers programs, including:

• Advanced Expression
• African Studies
  • African Studies Adjunct Major
  • African Studies Minor
• American Studies
  • American Studies Major
• Anthropology
  • Anthropology Major
  • Anthropology Minor
• Arabic
• Art History
  • Art History Major
  • Art History Minor
• Art Theory and Practice
  • Art Theory and Practice Major
  • Art Theory and Practice Minor
• Asian American Studies
  • Asian American Studies Major
  • Asian American Studies Minor
• Asian Languages and Cultures
  • Asian Languages and Cultures Major
  • Asian Humanities Minor
  • Advanced Asian Languages Minor
• Astronomy
• Biological Sciences
  • Biological Sciences Major
  • Biological Sciences Second Major for ISP Students
• Black Studies
  • Black Studies Major
  • Black Studies Minor
• Business Institutions
  • Business Institutions Minor
• Catholic Studies
• Chemistry
  • Chemistry Major
  • Chemistry Minor
  • Chemistry Second Major for ISP Students
  • Chemistry BA/MS
• Chicago Field Studies
• Chinese
• Classics
  • Classics Major
  • Classics Minor Concentrations
• Cognitive Science
  • Cognitive Science Major
  • Cognitive Science Minor
• Comparative Literary Studies
  • Comparative Literary Studies Major
  • World Literature Minor
  • Comparative Literary Studies BA/MA
• Computer Science
  • Computer Science Major
  • Computer Science Minor (Weinberg College)
  • Computer Science Second Major for ISP Students
  • Computer Science BA/MS
• Critical Theory
  • Critical Theory Minor
• Data Science
• Earth and Planetary Sciences
  • Earth and Planetary Sciences Major
  • Earth and Planetary Sciences Minor
  • Earth and Planetary Sciences Second Major for ISP Students
• Economics
  • Economics Major
  • Economics Minor
  • Economics BA/MA
• Empirical and Deductive Reasoning
• English
  • English Major
  • Creative Writing Major
  • English Minor
  • Creative Writing Minor
• Environmental Policy and Culture
  • Environmental Policy and Culture Adjunct Major
  • Environmental Policy and Culture Minor
• Environmental Sciences
  • Environmental Sciences Major
  • Environmental Sciences Second Major for ISP Students
• Ethical and Evaluative Thinking
• Ethics and Civic Life
  • Brady Scholars Program
• French and Italian
  • French Major
  • French Minor
  • Italian Literature and Culture Major
  • Italian Minor
  • French BA/MA
• Gender and Sexuality Studies
  • Gender and Sexuality Studies Major
  • Gender and Sexuality Studies Minor
• General Liberal Arts
• German
  • German Major
  • German Minor
  • German Studies Minor
  • Business German Minor
• Global Health Studies
  • Global Health Studies Adjunct Major
  • Global Health Studies Minor
• Greek
• Hebrew
• Hindi
• Historical Studies
• History
  • History Major
  • History Minor
• Humanities
  • Kaplan Humanities Scholars Program
• Integrated Science
  • Integrated Science Major
• International Studies
  • International Studies Adjunct Major
  • International Studies Minor
• Italian
• Japanese
• Jewish Studies
  • Jewish Studies Major
  • Hebrew Studies Minor
  • Jewish Studies Minor
• Korean
• Latin
• Latin American and Caribbean Studies
  • Latin American and Caribbean Studies Minor
• Latina and Latino Studies
  • Latina and Latino Studies Major
  • Latina and Latino Studies Minor
• Legal Studies
  • Legal Studies Major
  • Legal Studies Minor
• Linguistics
  • Linguistics Major
  • Linguistics Minor
  • Linguistics BA/MA
• Literature and Arts
• Materials Science
  • Materials Science Minor
• Mathematical Methods in the Social Sciences
  • MMSS Adjunct Major
• Mathematics
  • Mathematics Major
  • Mathematics Minor
  • Mathematics Second Major for ISP Students
  • Mathematics Second Major or Minor for MMSS Students
• Middle East and North African Languages
  • Arabic Minor
• Middle East and North African Studies
  • Middle East and North African Studies Major
  • Middle East and North African Studies Minor
• Molecular Biosciences
• Native American and Indigenous Studies
  • Native American and Indigenous Studies Minor
• Natural Sciences
• Neurobiology
  • Neuroscience Major
  • Neuroscience Second Major for ISP Students
• Neuroscience
• Perspectives on Power, Justice, and Equity
• Philosophy
  • Philosophy Major
  • Philosophy Minor
• Physics and Astronomy
  • Physics Major
  • Physics Minor
  • Physics Second Major for ISP Students
• Political Science
  • Political Science Major
  • Political Science Minor
• Portuguese
• Psychology
  • Psychology Major
  • Psychology Minor
• Religious Studies
  • Religious Studies Major
  • Religious Studies Minor
  • Catholic Studies Minor
• Russian
• Science in Human Culture
  • Science in Human Culture Adjunct Major
  • Science in Human Culture Minor
• Slavic Languages and Literatures
  • Slavic Languages and Literatures Major
  • Russian and East European Studies Minor
• Social and Behavioral Sciences
• Sociology
  • Sociology Major
  • Sociological Research Minor
  • Sociological Studies Minor
• Spanish & Portuguese
  • Spanish Major
  • Spanish Minor
  • Portuguese Language and Lusophone Cultures Minor
• Statistics and Data Science
  • Data Science Major
  • Data Science Minor
  • Statistics Major
  • Statistics Minor
• Swahili
• Turkish
• Urdu
• Writing Program

Requirements and Policies

The university has various requirements and policies, including:

• Courses and Credit
• Enrollment
  • Exams and Attendance
  • Withdrawal
• Grades
• Graduation & Degrees
  • Graduation Honors
• In-Person Arrival and Course Engagement
• Student Status
  • Academic Standing
  • Disciplinary Actions
  • Returning to the University
• Transcripts
• Transfer Credit
  • Test Credit
  • Transfer Types
• Undergraduate Registration Requirement

Additional Information

The university offers various additional information, including:

• Academic Calendar
• Academic Integrity
• Academic Support
• Additional Baccalaureate Options
• Dual Graduate & Undergraduate Degrees
• Dual Bachelor's Degrees
• Study Outside Northwestern
• Undergraduate Research
• Special Programs & Courses
• Military Programs
  • Naval Science