Course Offerings

Master of Science in Life Sciences, with an Option in Health Product Risk Management

Total of 30 credit hours including 24 course hours and six project/report hours. Students working towards the masters of science will identify a graduate committee to help direct their program of study.

Graduate Certificate in Health Product Risk Management:

Total of 12 credit hours (Certificate courses indicated by *)

Courses

*FST 5114 - Introduction to Risk Management for Health Products
Historical developments in perspectives on risk, survey of risk management models used by FDA, USDA and others. Common terminology, applications. (3H, 3C) Graduate standing.

*FST 5124 - Risk Management as a Business Strategy for Health Product Industries
Using enterprise risk management to stimulate innovation, minimize product liability, and address insurance coverage. Establishment of safeguards to avoid future legal actions and losses. Theories of risk management, product, stewardship, and product design. (3H, 3C) Graduate standing.

*FST 5134 - Risk Science in Pharmaceutical Processes: Tools and Techniques
Management of health care pharmaceutical product and process risks. International guidelines for clinical trials, pharmacovigilance, and quality risk management. Functional Analysis, Fault Tree Analysis, Failure Mode and Effects Criticality Analysis, Hazard Analysis and Critical Control Points, Hazard and Operability Study, and applications in currently-marketed pharmaceutical products and processes. (3H, 3C).

or

*FST 5144- Risk Science in Medical Device Processes: Tools and Techniques
Total life cycle risk management in medical device products and processes. CFR regulations, ISO Standards, Global Harmonization Task Force Guidelines for products/devices, JCAHO guidelines for hospital operations. Functional Analysis, Fault Tree Analysis, Hazard Analysis and Critical Control Points, Hazard and Operability Study. Team and Individual projects. Pre: 5114 (3H, 3C).

*FST 5154 - Risk Management Challenges of Emerging Health Product Technologies
Risk management to manage emerging developments in the fields of biotechnology, nanotechnology, wireless technology, etc. Compliance/regulatory issues and product development/manufacturing risks applied to emerging technologies. Application of risk management to address recent innovations or hypothetical products. Emphasis on development of novel approaches to technologically advanced health products. Pre: 5134 or 5144 (3H, 3C).

FST 5164 - Health Product Risk Communication & Incident Handling
Survey of international regulations and incident reporting systems worldwide. Case studies of solutions to post-market problems. Establishing a corporate culture of risk communication, and providing risk-based solutions to senior management. Pre: 5134 or 5144 (3H, 3C)

FST 5174 - Total Life Cycle Risk Management for Health Products
Application of risk management principles and systems engineering concepts to product, process, and support life cycles, iterative feedback loops for continuous improvement. Design/analysis of risk management systems for health product manufacturers, initiation of risk management systems in the corporate environment, application of information technology to integrate system elements and provide an enterprise solution. Managing risks at product conception and thereafter. Pre: 5134 or 5144 (3H, 3C).

FST 5184 - Economic Analysis of Health Product Risk
Risk management-based economic analysis and effect on corporate profitability. Survey of approaches for economic analysis of healthcare product risk as applied throughout product life cycle. Profit/cost and risk/benefit analyses, loss to the company, and loss to society as a result of adverse outcomes of healthcare product risks. Risk managed generation of short- and long-term financial benefits for healthcare product manufacturers. Development of models to analyze current issues based on available information. Pre 5174 (3H, 3C).