IT Quality Risk Management:

First a short intro to Life Science Quality Risk Management following the ICH Q9 process, and then we will go deeper on Quality Risk Management related to IT.

IT quality risk management involves identifying, assessing, and controlling risks that could impact the quality of IT systems and services

We will go through the GAMP 5 approach in details and methods to assess/mitigate/control risks

This is the first of 4 training sessions in the CSV Advanced part 1 course.

To receive a certificate, you need to participate in all 4 sessions of part 1.

The other sessions are:
Test Management

CSV Framework

IT Operation and Maintenance