Robert G. Schwarz
GXP-TrainCon
Referent:innen
Book this Course in combination with the Main Course on Cleaning Validation and save € 200!
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.
Zielsetzung
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 is in operation since 25 August 2023. The new Contamination Control Strategy (CCS) affects also the Cleaning Validation.
The Annex 1 Revision of is in operation since 25 August 2023. The new Contamination Control Strategy (CCS) affects also the Cleaning Validation.
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
Weitere Informationen
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.
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.
Conference language
The official conference language will be English.
Fees: Post-Course: Impact of Annex 1 Revision on Cleaning Validation (per delegate, plus VAT)
Non ECA Members EUR 790,-
ECA Members EUR 590,-
APIC Members EUR 690,-
EU GMP Inspectorates EUR 395,-
The conference fee is payable in advance after receipt of invoice.
Non ECA Members EUR 790,-
ECA Members EUR 590,-
APIC Members EUR 690,-
EU GMP Inspectorates EUR 395,-
The conference fee is payable in advance after receipt of invoice.
Book the Main Course in combination with the Post-Course Impact of Annex 1 Revision on Cleaning Validation and save € 200!
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation
Contact
Questions regarding content:
Mr Sven Pommeranz, +49 (0) 6221 84 44 47, pommeranz@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer, +49 (0) 6221 84 44 44, julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Thu., 26 November 2026, 09.00 - 12.30 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 790,- |
| EU/GMP Inspectorates*: | € 395,- |
| APIC Member Discount*: | € 690,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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