Dr Helmut Gaus
ECA Visual Inspection Group
Referierende
Felix Krumbein
Head ECA Visual Inspection Group
Save € 400 when booking the pre-conference course and the 15. Visual Inspection of Parenterals Conference together. Here you can register for both the Pre-Conference Course and the 15th Visual Inspection of Parenterals Conference.
Zielgruppe
This course is directed at staff from sterile operations involved in the 100% inspection process, that is production, quality and engineering. But also suppliers of primary packaging materials and inspections technology are target group of this Event.
Zielsetzung
The training course on visual inspection which takes place before the Conference gives you an understanding of the fundamentals of visual inspection of injectable products, applicable to manual and automated inspection. You will also learn how to implement an automated system based on manual inspection and how to qualify it
Skills you will develop through the course:
- Ensuring GMP-compliance in manual inspection
- Setting up a qualification strategy for automated systems
- GMP-compliant routine operation of automated systems
Programm
General requirements
- Requirements of the Pharmacopeia
- Defect categorisation
- Test kits for training, qualification and routine
Manual Inspection
- Qualification and training of personnel
- Standardisation of working conditions
- AQL in the manual inspection
From Manual to Automated Inspection
- Usage of the Knapp and the modified Knapp test
- Cross validation during the PQ Phase
- Evaluation matrices
Automated Inspection
- Importance of particle detection rates
- System-Suitability, Requalification and revalidation
Evaluation of Inspection Data & Batch Release
- Trending of inspection results
- AQL Testing
- Re-inspection – allowed or not?
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 EUR 1,090
APIC Members EUR 1,190
Non-ECA Members EUR 1,290
EU GMP Inspectorates EUR 645
The conference fee is payable in advance upon receipt of invoice.
ECA Members EUR 1,090
APIC Members EUR 1,190
Non-ECA Members EUR 1,290
EU GMP Inspectorates EUR 645
The conference fee is payable in advance upon receipt of invoice.
Save 400 EUR when booking pre-conference course and conference together.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Questions regarding content:
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Datum & Uhrzeiten
Tue,6 Oct 2026, 09:00-17:00 h
Times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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