Statistical Considerations for ICH Guidelines 2014

Key Topics

• ICH "Q" Series
  • Q2 Validation of Analytical Procedures
  • Q1 Stability Testing
  • Q5 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human of Animal Origin
  • Q3 Impurities in New Drug Substances
  • Q7 GMP for API
  • Q6 Specifications
• Introduction/Fundamentals - Statistics
  • Graphical Techniques
  • Summary Statistics
  • Confidence Intervals and Tolerance Intervals
  • Hypothesis Testing
  • Interactive Discussion/Questions
• Integrating Statistics
  • Design of Experiments and ANOVA - Q8
  • Regression - Q1
  • Probability - Q9
  • Sample Size - Q6
  • Interactive Discussion/Questions
• Statistical Tools in Action (Workshop)
  • Assay Validation
  • Developing a Risk Management Plan
  • Q8 Pharmaceutical Development
  • Setting Specifications
  • Q10 Pharmaceutical Quality System
  • Q9 Quality Risk Management

Who should Attend

Development, quality and research scientists from regulated industries, including:

• Assay Development Scientists
• Quality Managers
• Research Scientists
• Quality Analysts
• Risk Managers