Advanced Methods of Root Causes Analysis for ISO 14971 Risk Reduction

This 90-minute webinar on Advanced Methods of Root Causes Analysis, for medical device companies, will cover principles and methods of Root Cause Analysis (RCA) and review proven techniques for ISO 14971 Risk Reduction based on RCA.

Why Should You Attend:

Root Cause Analysis (RCA) is the most important tool in device recall investigations and for preventing the adverse events. Unfortunately there is substantial misunderstanding of the limitations of the tool and how to use it correctly. The result is often wrong judgments, wrong design changes, and wasted efforts. Doing it right will reduce costs. Using advanced methods will make a big difference in preventing recalls.

Attend this 90-minute training to learn proven techniques for root cause analysis and corrective actions from the presenter with over 25 years hands-on-experience.

Areas Covered in the Seminar:

• Principles of Root Cause Analysis (RCA).
• FDA Quality System Requirements for RCA.
• RCA from the point of view of the system.
• Root Cause Analysis methods.
• Role of RCA in Failure Mode and Effects Analysis.
• Using Fault Tree Analysis as RCA tool.
• Risk analysis based on RCA.
• Risk reduction based on RCA.