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Resource Center

“Are You Ready for Annex 1? Points to Consider When Doing an Annex 1 Self-Assessment” Presentation with Darius Pillsbury & Stephen Langille, Ph D.

10:30 AM-12:30 PM on Thursday, January 20th.

Annex 1 – Manufacture of Sterile Products provides guidance for the manufacture of sterile medicinal products for human and veterinary use and is part of the European Union’s EudraLex Volume 4 on Good Manufacturing Practice (GMP). This inclusive live webinar will provide an overview of the history and changes to Annex 1, cover many of the topics necessary to ensure readiness for Annex 1 compliance and describe the impact of this document on the global regulatory environment.

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