Felix Krumbein
Head ECA Visual Inspection Group
Referierende
Dr Helmut Gaus
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
To participate in a recording, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the recording, you can decide on what date you want to watch the training course online. Starting from the access date you entered during the registration process, the stream will be available to you for 7 days. Within this timeframe, you can start and stop the stream according to your needs.
When you register for the recording, you can decide on what date you want to watch the training course online. Starting from the access date you entered during the registration process, the stream will be available to you for 7 days. Within this timeframe, you can start and stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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
Recording from 6 October 2026
Duration of the recording: 4h 10min
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
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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