Program Overview:

Quality Systems

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.

Additional Information

In order to be considered for this program, applicants must possess a graduate degree must demonstrate the knowledge and skills equivalent to the following courses:

  • MSRC 401 Quality Systems: 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.
  • 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.

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:

  • QARS 460-0 Drug and Biologics Regulations
  • QARS 420-0 Quality Management
  • QARS 421-0 Regulatory Practices
  • QARS 425-0 QA Project Management
  • QARS 450-0 Medical Device Regulations