Felix Krumbein
Head ECA Visual Inspection Group
Referent:innen
Dr. Helmut Gaus
WinSol
Zielsetzung
The training course on visual inspection which takes place before the Particles 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 on the basis of the manual inspection and how to qualify it.
Hintergrund
In most cases particles found in parenteral medicines will lead to a quarantined product or even to the recall of the product – as we have seen in the last years in the cases of several Pharmaceutical companies. Responsible staff in charge will have to start root cause analysis to find the source of the particles and will have to do an evaluation of batches already shipped.
There is still confusion within the global pharmaceutical Industry with regard to the requirements for testing for visible particles. After the USP chapters <790> and <1790> were published, things have become much clearer, at least for the US. In Europe chapter 5.17.2 of the European Pharmacopoeia now also gives further advice. However, many questions remain, e.g. concerning training, re-testing, detection capabilities and revalidation of inspection systems.
Furthermore, there has been a recognisable trend towards automated inspection machines throughout the last years. High expectations are also placed on the use of artificial intelligence. The challenge for pharmaceutical companies is to find a suitable machine for their products and to determine reasonable inspection parameters during qualification and validation. But also during routine process there are questions arising like re-testing and the usage of test-sets, doing AQL-Testing as well as the Adjustment of parameters of the vision system.
We will address those topics during the conference and discuss and answer questions on
- The latest compendial requirements concerning particulate matter (EU & US)
- How to comply with FDA’s new guidance on Visual Inspection
- Compliance with the new EU Annex 1
- Implementation of artificial intelligence in the automated inspection process
- Reduction of false rejects in automated inspection Systems
- How to inspect hard-to-inspect containers
- How to set up a company-wide particle reduction Programme
- How to transfer a visual inspection process during a site change
The fundamentals, such as training of operators in Manual inspection, AQL testing, trending and the validation of an AVI System are content of the Pre-Conference course on November 5th.
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.
Programm
Gesamtes Programm als PDF herunterladen
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?
| ECA-Member*: | € 790,- |
| Non ECA Member*: | € 990,- |
| EU/GMP Inspectorates*: | € 495,- |
| APIC Member Discount*: | € 890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
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Aufzeichnung nicht verfügbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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