Dr Helmut Gaus
WinSol, previously Boehringer Ingelheim
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 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
- 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.
Date & Technical Requirements
Date
Thursday, 15 May 2025; 13.30 – 17.00 h CEST
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/onlinetraining-technical-information you will find all the Information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
General Requirements
- Requirements of the different Pharmacopeia
- Defect categorisation
- Test kits for training, qualification and routine
Manual Inspection
- Organisation of the manual inspection
- Training of personnel
- Qualification of personnel
- Standardisation of working conditions
- AQL testing in the manual inspection
- Trending of inspection data & batch release
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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