Pre-Course: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

With the revised version of Annex 1 coming into force in August, this workshop aims at giving you an overview of important changes that impact cleaning and Cleaning Validation which may not be seen at the first glance. As integral topic of the new Contamination Control Strategy (CCS), it will also be in the main focus of authorities during inspections of sterile medicinal products. Some of the strategies in Annex 1 may even become “state of the art” for non-steriles in the upcoming years. This is already explicitly mentioned in scope of the new Annex 1. It will be elaborated how to align your Cleaning Validation strategy with this, highlighting points to consider when implementing those changes in requirements into your daily Cleaning Validation business.

The Annex 1 Revision of the EU GMP Guide was finalised in 2022. Previously there were two drafts (2017 & 2020), now the final version will come into force at 25th August 2023. The new Contamination Control Strategy (CCS) hugely affects Cleaning Validation.

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