GMP Webinar: Endotoxin Highlights – the Essence of Experts’ Thinking
Im Auftrag der ECA Academy

GMP Webinar: Endotoxin Highlights – the Essence of Experts’ Thinking Im Auftrag der ECA Academy

Seminar Nr. 16578

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Sprecher

Dr Johannes Reich, Microcoat Biotechnologie GmbH, Germany

Johannes Reich studied business administration and chemistry in Regensburg. His doctoral thesis was 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 for Profos. Currently he is Managing Director at Microcoat Biotechnologie GmbH with focus on the Endotoxin and Pyrogen testing

Hintergrund

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?
But although the question about alternative methods like MAT or Recombinant Factors is frequently asked – what is the status of these methods in the Pharmacopoeias? What is the authorities thinking on their use.

These are the questions the pharmaceutical microbiologists as well as those responsible for the release have to deal with.

Zielgruppe

Laboratory management and staff of pharmaceutical microbiology
Microbiologists and laboratory assistants from contract
laboratoriesAuthority representatives involved in the topic
Scientific staff from the area Pyrogen and/or Endotoxin testing
QA staff who has to evaluate endotoxin data and handle deviations

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.htm you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

  • Background
  • Conflictive observations
  • Understanding conflictive results
  • Optimization of current detection methods
  • Regulatory review
  • Development in Pharmacopoeias

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