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
- Statistical detection
- Accuracy
- LOD & LOQ
- Linearity
- Precision
- Most Probable Number
- Specificity
- Accuracy
- LOD
- Two-factor experiment
- Multi-factor experiments
- Approaches qualitative & quantitative methods
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager" Learn more
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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Seminar Programme as PDF
