FDA´s former Senior Policy Officer Grace McNally speak at ECA´s Launch Conference
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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?
- Revision of the main part
- New chapter about GMP contracting of qualification services
- New Appendix Remote FAT/SAT
- Complete revision Appendix Integrated Qualification Core Concept
- Revision chapter electronic documentation
- Revision chapter categorisation and template
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.