Statistical Elements of Implementing ICH Quality Guidelines is a seminar that addresses the unique challenges facing quality functions of pharmaceutical and biotechnology companies.
Statistical Elements of Implementing ICH Quality Guidelines covers topics such as:
- Comparative analyses and regression analysis
- FDA requirements to ICH guidelines
- The appropriate sample size
- The difference between confidence and tolerance intervals
- Statistical tests for comparisons, stability, validation, impurities
- The probability of risk
Statistical Elements of Implementing ICH Quality Guidelines brings together:
- Analytical Validation scientists and personnel
- Quality Managers
- Quality Control Personnel
- Assay Development Scientists
- Research Scientists
- Quality Analysts
- Risk Managers
