Course No 9344
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Dr Helmut Gaus,
Director Quality Control at Boehringer Ingelheim
Dr Tobias Posset,
Head of Production Support Roche Diagnostics
This training course on visual inspection will give 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. The course also includes an AQL training, that is you will learn how to use AQL tables to set defect limits and how to evaluate batch inspection data.
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, the latter as a draft, things have become much clearer, at least for the US. But still, lots of questions arise, e.g. concerning re-testing, detection capabilities and revalidation of inspection systems.
Furthermore there has been a recognisable trend towards automated inspection machines throughout the last years. 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 the permission of re-testing and the usage of test-sets and setting AQL-Levels.
We will address those topics during the conference and discuss and answer questions on
The latest compendial requirements concerning particulate matter
Trending and monitoring of visual inspection data
Understanding the real meaning of detection capabilities
How to select an appropriate inspection system
Operation of automated system from qualification to routine
Skills you will develop through the course:
Ensuring GMP-compliance in manual inspection
Setting up a qualification strategy for automated systems
Usage of statistical tools for assessing inspection data
GMP-compliant routine operation of automated systems
Content of the course in detail:
Requirements of the Pharmacopeia
Test kits for training, qualification and routine
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
Importance of particle detection rates
System-Suitability, Requalification and revalidation
Evaluation of Inspection Data & batch Release
Trending of inspection results
Re-inspection – allowed or not?