Outlines
Introduction to Quality Risk Management
How Risk Management could work for your organization?
QRM tools
QRM process
Risk Management plans (RMP)
QRM across the product lifecycle
Case Studies
Guideline on Quality Risk Management (QRM) was incorporated as GMP Annex 20 by the MHRA, PIC/S and the EMEA.
GMP Annex 11 is also currently under revision to include a clear reference to a risk-based approach for determining the level of Validation.
Introduction to Quality Risk Management
How Risk Management could work for your organization?
QRM tools
QRM process
Risk Management plans (RMP)
QRM across the product lifecycle
Case Studies