Statistical Elements of Implementing ICH Quality Guidelines

Statistical Elements of Implementing ICH Quality Guidelines is a seminar that addresses the unique challenges facing quality functions of pharmaceutical and biotechnology companies.

Topics

• 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

Who should Attend

• Analytical Validation scientists and personnel
• Quality Managers
• Quality Control Personnel
• Assay Development Scientists
• Research Scientists
• Quality Analysts
• Risk Managers