Robert G. Schwarz
GXP-TrainCon
Referierende
Book this Course in combination with the Main Course on Cleaning Validation and save € 200!
Zielgruppe
The Main Course and the Porst-Cpurse 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 is in operation since 25 August 2023. The new Contamination Control Strategy (CCS) affects also the Cleaning Validation.
Programm
With the Post-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
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT)
ECA Members € 590
APIC Members € 690
Non-ECA Members € 790
EU GMP Inspectorates € 395
The conference fee is payable in advance after receipt of invoice.
APIC Members € 690
Non-ECA Members € 790
EU GMP Inspectorates € 395
The conference fee is payable in advance after receipt of invoice.
Book this course in combination with the Main Course on Cleaning Validation and save € 200!
Conference language
The official conference language will be English.
The official conference language will be English.
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.
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.
You cannot attend the Live Event?
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Contact
Questions regarding content:
Mr Sven Pommeranz, +49 6221 84 44-47, pommeranz@concept-heidelberg.de.
Questions regarding Organisation:
Ms Julia Grimmer, +49 6221 84 44-44, julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Thu, 29 April 2027, 09:00-12:30 h
All times mentioned are CEST.
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
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Validation Manager"
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E-Mail: info@concept-heidelberg.de
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