Template for a Quality Risk Management Plan

Status: Completed

This file is a template for a Master Plan that can be used by companies to define how their Quality Risk Management (QRM) program will be conducted through integration of knowledge gained from formal risk assessments, operational alerts, change controls and inspections as required by ICH Q9 Quality Risk Management. It also addresses how information on higher risks will be communicated to management and the quality unit through a risk register intended to increase visibility and provide focus in discussions on risk control and mitigation.

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