. European Microbiology Conference 2017 .

Workshop “Validation of Microbiological Methods”

on 11-12 May 2017



For the validation of microbiological test methods, several experiments must be performed to demonstrate that the new method is capable of detecting and counting organisms in test samples and at least as good as the compendial method. To quantify the performance, statistical methods form an indispensable tool. This workshop will provide information on the types of experiments and the statistical analyses that may be performed to estimate the validation Parameters of the new rapid methods. The methods will be illustrated with real cases on the Validation of rapid microbiological test methods.



Pieta IJzerman-Boon
Principal Statistician MSD

Prof. Edwin van den Heuvel
University of Technology, Eindhoven, The Netherlands



General Part

  • Guidelines
  • Equivalence
  • Statistical detection
  • Proposed Strategies


Quantitative Methods

  • Statistical detection
  • Accuracy
  • LOD & LOQ
  • Linearity
  • Precision


Qualitative Methods

  • Most Probable Number
  • Specificity
  • Accuracy
  • LOD



  • Two-factor experiment
  • Multi-factor experiments
  • Approaches qualitative & quantitative methods


Closing remarks