At ECA´s online Launch Conference 16/17 November 2021 ECA´s Good Practice Guide Integrated Qualification and Validation in the new version 2.0 will be published. What´s new in this new version?
But what is the regulators' opinion on such a guide which describes modern aspects towards a streamlined qualification and the interaction with process validation? An EU inspector will provide his thoughts. Further, Grace McNally, FDA´s former Senior Policy Officer, who chaired the workgoup, which has developed FDA´s General Principles and Process Validation Guidance will provide her perspective as well.
In addition, a member of the ISPE expert group, who developed the Commissioning & Qualification Baseline Guide No 5, Version 2, will compare ISPE´s Guide with ECA´s Good Practice Guide.
To find out more, please visit the official Launch Conference website.