Statistics for Microbiological Validation

After-Conference Workshop on 29/30 June 2023


  • Regulatory Background
  • Statistical Analysis in line with Guidelines
  • Quantitative Methods
  • Qualitative Methods

Target Audience

This conference is of interest to professionals in microbiology from

  • Pharmaceuticals and Biopharmaceutical Companies
  • Academic Research Institutions
  • Government Agencies
  • Contract Service Laboratories

who are involved in implementation and validation of microbiological test methods.


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 alternative or rapid methods. The methods will be illustrated on real cases using software.


Pieta IJzerman-Boon
Principal Statistician MSD

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


General Part

  • Guidelines
  • Basic Statistics
  • Measurement Analysis
  • Equivalence
  • Statistical Detection

Quantitative Methods

  • Accuracy
  • LOD & LOQ
  • Linearity
  • Precision

Qualitative Methods

  • Accuracy
  • (Generalized) Most Probable Number
  • LOD
  • Specificity

Programme - Download



Programme of the Workshop as PDF.