Risk Management

 
Course Outline:
• Why is risk management important? 
        » Objectives of risk management 
        » Classification of medical devices

• Basics of risk management 
        » definitions and overview of risk management 
        » the ISO 14971 
        » how risk management relate to the medical device industry

• General requirements for risk management 
        » The life cycle of medical device 
        » Risk management process flow 
        » Management responsibilities & qualification of personnel 
        » Risk management plan and file

• Risk analysis 
        » Risk identification 
        » Risk estimation

• Risk evaluation 
        » Risk acceptability

• Risk control & overall residual risk 
        » Risk control options 
        » Residual risk evaluation

• Risk management report 
        » Content of report

• Production & post production information 
        » Collection and review of information

• Risk analysis techniques 
        » Overview of the risk techniques: 
        » Preliminary Hazard Analysis 
        » Fault Tree Analysis 
        » Failure Mode and Effect Analysis (FMEA) 
        » Hazard and Operability Study (HAZOP) 
        » Hazard Analysis & Critical Control Point (HACCP)

Trainer: Ms. Gan Poh Siew (PS Gan)

Ms. PS Gan, a Bachelor of Science in Chemistry graduate, has 8+ years of practical and managerial experience having held local and oversea positions as Quality Management Representative in a multinational company.

Her expertise covers implementation of quality management system, design control, process validation and ISO audits.