Robert G. Schwarz
GXP-TrainCon
Referent:innen
Book this Course in combination with the Main Course on Cleaning Validation and save € 200!
Zielsetzung
With the revised version of Annex 1 coming into force in August, this pre-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 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.
Hintergrund
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.
Zielgruppe
The Pre-Course 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.
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.
Programm
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
| ECA-Member*: | € 490,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 345,- |
| APIC Member Discount*: | € 590,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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