Hazard Analysis following ISO 14971 2016

Topics

• Hazard analysis process explanation using a template
• Explanation of terms
• Integration of human factors studies into the hazard analysis will be explained
• Hazard analysis examples will be covered step by step
• Residual risk will be shown by example

Who should Attend

• QA
• Engineering personnel
• Management
• Software developers, IT
• Project Leaders
• Senior Management
• R&D and Engineering Staff
• Regulatory Affairs
• CAPA and P&PC personnel desiring to reduce or redirect investigation and validation costs without sacrificing product safety and/or warranty costs
• All charged with new product development, regulatory submissions, initiating / overseeing product hazard analysis and remediation