Effective Hazard Analysis to meet FDA and ISO13485 2003 Risk Management Requirements - Webinar By GlobalCompliancePanel

(bit.ly)

Why should you attend: Performing requires Hazard and Risk Analysis often poses a challenge for development teams. How detailed does the analysis have to be? What is the difference between hazard and harm, hazard and hazard cause, Hazard analysis and FMEA, etc.? How do we combine the risk rating when different mitigation measured are used simultaneously? This presentation will try to answer all these questions and provide a partial guidance on how to effectively perform a Hazard and Risk Analysis.

Areas Covered in the Session:
Structure of a Risk and Hazard Analysis document
Stakeholders and participants
How to conduct a hazard analysis meeting

Meeting ground rules
Hazard and Harm characteristics

Methods to identify potential hazards
Risk and Risk Rating methods
Risk mitigation strategies
Risk assessment and Residual Risk
Who Will Benefit:
Project Leaders
Design Engineers
Regulatory
Quality