GMP Webinar: Endotoxin Masking - Low Endotoxin Recovery Update
Speakers
Johannes Reich, University Regensburg,
Germany
Johannes Reich studied business administration and chemistry in Regensburg. Currently, he is working on his doctoral thesis on “function-structure relationship of Lipopolysaccharide with recombinant factor C test systems” at the Institute for physical and theoretical chemistry. He deals with the problems of modern endotoxin detection methods and with the problem of low endotoxin
recovery. In the meantime he worked as product manager at Profos AG in Regensburg.
Background
In the last years the LAL test has become the preferred system to test for endotoxins – for the in process control as well as in the final inspection – and it is anchored in the pharmacopoeias. However, in the recent past, the problem of low endotoxin recovery employs the pharmaceutical microbiology. Masking – or not? Evidence gaps? And how can I close them? And how to evaluate?
These are the questions the pharmaceutical microbiologists as well as those responsible for the release have to deal with.
Target Group
Laboratory management and staff of pharmaceutical microbiology
Microbiologists and laboratory assistants from contract laboratories
Authority representatives involved in the topic
Scientific staff from the area pyrogen testing
QA staff who has to evaluate endotoxin results and deviations
Programme
In this webinar you will get an insight into the current situation:
1) Background
2) Conflictive observations
3) Understanding conflictive results
4) Optimization of current detection methods
5) Regulatory review
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