Quality Systems Management Advanced Certificate

The quality systems certificate 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. A work force, including chemists, scientists, technicians, and managers, proficient in the principles and practices of quality, is a central concern of companies. Certification is a mark of excellence which demonstrates that the certified individual has the knowledge to assure the quality of products and services. Quality Systems course work supports preparation for the ASQ (American Society for Quality) certifications in the areas of: Quality Improvement Associate, Quality Process Analysts, Quality Auditor, Quality Engineer, Pharmaceutical GMP professional, Six Sigma Green Belt and Lean Certifications as well as Manager of Quality/Organization Excellence certification.



About the Quality Systems Management Advanced Certificate

Quality Systems Management Course Schedule

The Quality Systems Management Course Schedule page provides you with detailed information on the program's offerings.

Quality Systems Management Faculty

You can find a full listing of our instructors in this certificate program on the Quality Systems Management Faculty page.

Admission for the Quality Systems Management Advanced Certificate

Applicants to this certificate program must hold a graduate degree from an accredited U.S. college, university or its foreign equivalent. A competitive graduate record that indicates strong academic ability is required. Work or research experience in clinical, computing or information technology fields is highly desirable but not a requirement for admission.

This certificate program requires prerequisite coursework or knowledge. For more information, view the "additional information" section on the program overview page of your chosen certificate.

A list of admission requirements can be found on our Quality Systems Management Admission page.

Quality Systems Management Tuition

Tuition costs can vary for each of our programs. For the most up-to-date information on financial obligations, please visit our Quality Systems Management Tuition page.

Quality Systems Management Registration Information

Our Quality Systems Management Registration Information page outlines important dates and deadlines as well as the process for adding and dropping courses.

Additional Information

Applicants must possess a graduate degree and must demonstrate the knowledge and skills equivalent to the following courses prior to applying to this program. Please see below for more information:

  • MSRC 409 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.
  • 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.

Applicants who do not have this prior knowledge and who want a more comprehensive course of study should consider the Master of Science in Regulatory Compliance degree.

Find out more about Northwestern's Quality Systems Management Advanced Certificate

Quality Systems Management Required Courses

To earn a certificate, students must complete the following four courses.

  • QARS 420 Practical Quality Management
  • QARS 421 Applied Quality and Regulatory Practices
  • QARS 425 Quality Assurance Project Management

and one of the following courses:

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

In some cases, students who have completed equivalent coursework previously may be allowed to replace the required course with another course in the field.

Please note that courses completed in the certificate program cannot be transferred to the corresponding graduate degree.

Courses:Course Detail
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.


View QARS 425-0 Sections
Drug and Biologics Regulations QARS 460-0

Students 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. .

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


There is no available section.