Mini Workshop

How to Define Critical Processes and Critical Data

Thursday, September 30, 2021, 9:45 AM - 11:15 AM

ICH E6 R2 expects companies to implement RBQM based on critical processes and critical data in their studies. Sometimes, however, it is rather difficult to identify those critical processes and critical data since almost everything in a study seems to be critical (or at least should be). This mini workshop will discuss how to identify those critical processes and critical data and help the workshop participants to get the process started.

The participants will learn how to transform the critical processes and critical data into a risk statement which can commonly be understood by everybody in an organization.

Faculty: