Pyrogen Testing School and Advanced Operator Training

 
 

Understanding Good Practice in Pyrogen Testing

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Two Full Days Course

“Each person engaged in all phases of pharmaceutical manufacture should have the education, training, and experience to do his or her job. Training curricula should be established for each laboratory staff member specific for his or her job function. Training records should be current, documenting the microbiologist’s training in the proper revision to the particular SOP.” USP

Overview

The course is based on the most recent editions of the international guidelines with special attention to the recent changes to the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). It provides an in-depth review of technical and regulatory information on endotoxin and pyrogen testing.

Training Program

Interactive Workshop

  • Use of the MilliporeSigma MAT system
  • Execution of a complete test according to the quantitative method
  • Analysis of the results
  • Answers to specific user-related questions
What will you receive?
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What are the benefits of attending this course?
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  • You will understand the current requirements from pharmacopoeias and other international guidelines and be familiar with the correct pyrogen testing procedure with Monocyte Activation Tests from product specific validation to routine test result interpretation.
  • You will get hints and tips to optimize the operating steps.
  • You will understand and identify root causes for common handling issues.
Who should attend?
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This course is dedicated to users of endotoxin or pyrogen testing products. It is designed for operators, supervisors and managers of QC laboratories and it is also of interest for personnel from QA, Regulatory Affairs and Validation departments.

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Optimize your QC lab workflow and ensure regulatory compliance.

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