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Risk Management for Regulated Industries
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.
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.
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