- Datum:
-
- Webinar
Fundamentals of Manual Visual Inspection - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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 and 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
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
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/