Dr. Helmut Gaus
ECA Visual Inspection Group
Referent:innen
Zielsetzung
This training course gives you an understanding of the fundamentals of visual inspection applicable to the manual inspection of injectable products. This covers the following aspects of visual inspection: organisation, training, qualification and the inspection process itself. You will also learn about AQL testing and trending of inspection data.
Hintergrund
The 100% visual inspection of sterile injectable products is a requirement originating from the Pharmacopoeias, e.g. from the US USP or the European PharmEur. But there is still confusion within the global Pharmaceutical industry with regard to the requirements for testing of visible particles. After the USP chapters <790> and <1790> were published, things have become much clearer, at least for the US. In Europe the new chapter 5.17.2 of the European Pharmacopoeia now also gives further advice. However, many questions remain, e.g. concerning training, qualification, detection capabilities and Organisation of the visual inspection and the AQL testing.
- We will address those topics during the conference and discuss and answer questions on:
- The latest compendial requirements concerning particulate matter
- Compliance with the revised Annex 1 (draft)
- Training and qualification of operators in the Manual inspection
- Setup of test kits for training and qualification
- Trending and monitoring of visual inspection data
- Correct AQL testing as part of the batch release
- Re-inspection of defect fractions
Zielgruppe
This one-day training is directed at everybody involved in the manual 100% inspection of sterile injectables. As the fundamentals are explained in a very comprehensive way, the course is very popular with beginners and medium experienced staff.
Technical Details
To participate in an on demand training course or webinar, 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 on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & 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.
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & 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.
Programm
General Requirements
- Requirements of the different Pharmacopeia
- Defect categorisation
- Test kits for training, qualification and routine
Manual Inspection
- Organisation of the manual inspection
- Qualification of personnel
- Training of personnel
- Standardisation of working conditions
- AQL in the manual inspection
- Trending of inspection data & batch release
Recording from 28 June 2022
Duration of the recording: approx. 1,5 h
Duration of the recording: approx. 1,5 h
| ECA-Member*: | € 690,- |
| Regular Fee*: | € 790,- |
| EU/GMP Inspectorates*: | € 395,- |
| APIC Member Discount*: | € 740,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Weitere Termine vor Ort nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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