Tuesday, 11 November 2025 13.00 - 16.30 h
Speakers
Robert G. Schwarz, FH Campus Vienna, Austria
Objectives
With the revised version of Annex 1 that became effective in August 2023, this course 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 the 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.
Background
The Annex 1 Revision of the EU GMP Guide was finalised in 2022. Previously there were two drafts (2017 & 2020), the final Version became effective on 25th August 2023. The new Contamination Control Strategy (CCS) hugely affects Cleaning Validation.
Target Group
The Pre-Course Workshop and the Main Course both are directed at staff of R&D, production and quality assurance involved in cleaning validation. They also address engineering companies and manufacturers of cleaning devices/equipment interested in learning more about the pharmaceutical industry’s viewpoint and in exchanging experiences.
Programme
With the Pre-Course we cover:
- Regulatory requirements of Annex 1 regarding Cleaning Validation & Cleaning (incl. potential topics stated “between the lines”)
- Annex 1, Annex 15 and EMA “Shared facilities Guideline” – harmonized, extended requirements or even contradictions!?
- Annex 1 & Cleaning Validation – practical approaches
Date & Technical Requirements
Date
Tuesday, 11 November 2025, 13.00 h - 16.30 h (CET)
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Tuesday, 11 November 2025, 13.00 h - 16.30 h (CET)
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.