Method
Flexible
Term
SPRING
Units
3.0 QUARTER UNITS
Cost
$875

Skills you will gain

  • Risk Identification & Mitigation: Develop skills in identifying hazards and ranking risk mitigation activities across various industries.
  • Hazard Analysis Expertise: Learn to conduct hazard and risk estimation, applying techniques like Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis.
  • Regulatory Compliance Mastery: Understand ISO 14971 documentation requirements and create regulatory-compliant risk management plans and reports.
  • HACCP Analysis Application: Gain proficiency in performing Hazard Analysis and Critical Control Points (HACCP) for process risk management.
  • Risk Management Documentation: Prepare structured Risk Management Plans and Files for medical devices, pharmaceuticals, diagnostics, and more.

Course Description


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.

 


 

Topics Include

  • Risk Management
  • Annex A Characteristics
  • Hazard Analysis

Syllabus Library
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This course applies to these programs:

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