This course discusses how risk management is applied in the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries. Lectures and workshops delve into risk management concepts and tools, including hazard identification, hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), mitigation application, regulatory requirements, the creation of risk management plans, reports and files, how to conduct Risk Management Reviews, and what might be audited in your Risk Management System. By the end of the course, you'll be able to conduct risk management for a variety of products, processes and services within the biomedical industries and beyond.

Learning Outcomes

At the conclusion of the course, you should be able to

• Develop an understanding of Risk Management as part of the product and process development cycle by defining a hazard, levels of risk, types of harm, and to rank risk mitigation activity
• Prepare a Hazard Analysis including hazards, hazardous situations, harms, and understand risk estimation
• Perform a HACCP (Hazard and Critical Control Points) analysis as a qualitative process hazard analysis for process risk management for any process
• Assess the application and results that critical tools of quality such as a Failure Modes and Effects
• Analysis and Fault Tree Analysis can provide
• Compose and document mitigations to risk in a suitable regulatory format
• Enumerate the fundamental documentation requirements of ISO 14971 (Medical Devices – application of risk management to medical devices)
• Prepare a Risk Management Plan in a device, a pharmaceutical product, a diagnostic product, or a process, which describes the tasks involved in successfully leading an ISO Quality System implementation project from start-up through Registration
• Apply structured qualitative and quantitative risk management concepts and tools leading to a documented Risk Management Plan and Risk Management File that can be used in any due diligence for reducing risk in product, process or service development

Topics Include

• Risk Management
• Annex A Characteristics
• Hazard Analysis

Working knowledge of:

• Google Workspace or Microsoft Office to submit assignments
• Canvas navigation links, modules, and using the inbox to communicate with the instructor

Additional Information

Please review section notes to view the full schedule.

Prerequisite(s): Students need to possess reasonable experience, background, and/or theoretical knowledge of medical devices, diagnostics or pharma. "Quality Systems for Medical Devices FDA QSR and ISO 13485" formerly titled "Medical Device Quality Systems" and "Introduction to Medical Device Regulation," or "Regulation of Medical Devices and Diagnostics," or "Medical Devices: Regulatory Strategies and Marketing Pathways," or equivalent experience.