Felix Krumbein
Head ECA Visual Inspection Group
Referierende
- Technical and Operational Features
- Two-stage-inspection approach
- Use cases
A basic understanding of manual inspection is highly recommended. The course Fundamentals of Manual Visual Inspection takes place in the morning of the same day.
Zielgruppe
This course is aimed at professionals involved in the visual inspection of parenteral/injectable products who want to understand how semi-automated visual inspection (SAVI) is set up, qualified, and run in a GMP-compliant way.
Zielsetzung
This training course provides a focused introduction to the fundamentals of semi-automated visual inspection (SAVI) for injectable products. It explains how SAVI differs from manual inspection and from fully automated systems, and what this means in practice for system setup, qualification, and GMP-compliant operation.
The course covers key technical aspects of SAVI equipment and settings, including the selection of backgrounds and illumination, and how to ensure a 360-degree inspection.
In addition, the training addresses how test kits are adapted for use in SAVI, what a qualification strategy (including worst-case conditions) can look like, and when computer system validation is necessary in the SAVI context. A further focus is routine operation: participants learn how inspection speed is managed in practice and which rules for break times and break durations are typically defined to support consistent inspection performance.
Typical use cases are also discussed, including how SAVI may be applied from an economic point of view depending on batch sizes and the number of batches per year. Additionally, we talk about inspection concepts, how SAVI may contribute to an efficient inspection process combining SAVI in a two-stage-inspection with AVI.
Programm
- Technical details: black/white background? mirrors, 360-degrees, inspection window, illumination
- Optical magnification – yes or no
- Adaptation of test kits – composition and adapting kits to individual inspection strategies
- Use cases: batch sizes, batches per year
- Two-stage-inspection approach using SAVI
- Routine operation: inspection speed, rules for break times / durations
- Assignment of recipe management, automation, ejection, counting, and lighting in OQ and PQ
- Worst-case conditions in qualification & bracketing
- Computer system validation - categorisation
- Trending
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.
Fees (per delegate, plus VAT)
ECA Members EUR 590
Non-ECA Members EUR 690
EU GMP Inspectorates EUR 490
The conference fee is payable in advance upon receipt of invoice.
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.
Conference language
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
Datum & Uhrzeiten
Thursday, 4 March 2027
14:00 to approx. 16:45 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 490,- |
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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