On-demand Webinar Recording

How to ensure compliance with Annex 1

EudraLex Volume 4, Annex 1 “Manufacture of Sterile Medicinal Products” was completely revised and published in August 2022 with the expectation that Companies would be compliant per August 2023. This looks like plenty of time to assess the level of Compliance and come up with a remediation plan to close potential gaps. However, Organisations still struggle how to make this assessment, in particular for Small Medium Enterprises (SMEs).

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SPEAKERS:

Patrick Nieuwenhuizen

Director Principal Consultant, Cencora PharmaLex

Londa Ritchey

Quality Director, Quality Management & Compliance, Cencora PharmaLex

This webinar will discuss these challenges based on our experiences within the industry and how Companies can have a structured approach helping them to make the assessment. We will go into Quality Risk Management (QRM) and how it is embedded within the Annex 1, that QRM and Contamination Control Strategy (CCS) go hand in hand and keep it a “live” document.

The webinar also goes into some examples of the challenges aging facilities can face.

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