FDA´s former Senior Policy Officer Grace McNally speak at ECA´s Launch Conference

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.

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