Statistical Elements of Implementing ICH Quality Guidelines

Statistical Elements of Implementing ICH Quality Guidelines is a seminar that provides professionals with statistical approaches and guidance to implement ICH Quality guidelines effectively in pharmaceutical development and manufacturing.

Key Topics

• Review of ICH Quality Guidelines (Q Series)
• Fundamentals of statistics and hypothesis testing
• Analytical validation and assay validation
• Stability testing and shelf-life analysis
• Pharmaceutical development and lifecycle management
• Quality risk management planning
• Impurities and specifications setting
• Design of experiments (DOE) and sample size calculations
• Graphical techniques and statistical analyses
• Continuous manufacturing and analytical procedure development
• Comparative statistics and regression analysis
• Good manufacturing practices and pharmacopoeias
• Quality systems and biotechnology product quality

Who should Attend

• Analytical validation scientists and personnel
• Quality managers and quality control personnel
• Assay development scientists
• Research scientists and quality analysts
• Risk managers

ICH - International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use