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Risk Assessment and Risk Management Training

Overview

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.

 

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

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