Statistics for Microbiological Validation
After-Conference Workshop on 29/30 June 2023
Highlights
- 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.
Abstract
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.
Speakers
Pieta IJzerman-Boon
Principal Statistician MSD
Prof. Edwin van den Heuvel
University of Technology, Eindhoven, The Netherlands
Programme
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
