Post-conference workshop Validation of Microbiological Methods

Post-conference workshop Validation of Microbiological Methods

Prague, Czech Republic

Course No 16059


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Walid El Azab, Steris, Belgium

Thomas Brinz, Bosch, Germany

Marja Claasen-Willemse, MSD, The Netherlands

Dr Sven M. Deutschmann, Roche Diagnostics, Germany

Carolin Fromm, Labor L+S AG, Germany

Barbara Gerten, Merck, Germany

Prof. Edwin van den Heuvel, The Netherlands

Pieta IJzerman-Boon, MSD, The Netherlands

Gurpinder Kaur, University Freiburg, Germany

Dr Petra Rösch, University Jena, Germany

Jim Polarine, Steris, USA

Kevin Williams, GE Analytical Instruments, USA

IMPORTANT information for the post-conference Workshop!

Please note that a laptop is needed for the practical exercises. Also, the “Minitab” software must be installed on this computer. You can download a 30 days trial version of this sofware here:
https://www.minitab.com/en-us/products/minitab/

Programme

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.

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

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