Pyrogen Testing School and Advanced Operator Training

 
 

Understanding Good Practice in Pyrogen Testing

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Comprehensive courses

“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

Training Program

For more information about our course program and schedule please download our printable course description
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Pyrogen Testing School @ Merck

  • Use of the Merck MAT system
  • Execution of a complete test according to the quantitative method
  • Analysis of the results
  • Answers to specific user-related questions
  • Duration: 2 days
  • Available in our central location only (Molsheim, France) for 2 to 4 participants

Pyrogen Testing Advanced Operator Training @ Customer Site (AOT)

  • Theoritical introduction about Merck MAT system and procedure
  • Execution of a complete test according to the quantitative method
  • Analysis of results
  • Final examination
  • Duration: 2 half days
  • Available at customer site only
What will you receive?
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What are the benefits of attending?
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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.
What are the benefits of attending the Advanced Operator Training?
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  • You will learn how to perform a test under actual conditions of use.
  • You will be trained on optimal handling of the kit and analysis software.
  • You will get tips and tricks to optimize the operating steps.
Who should attend?
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The Pyrogen Testing School 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.

The Advanced Operator Training is dedicated to operators and lab technicians executing pyrogen tests.

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