Statistical Considerations for ICH Guidelines 2014 is a seminar that covers topics such as:
- 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
Statistical Considerations for ICH Guidelines 2014 brings together development, quality and research scientists from regulated industries, including:
- Assay Development Scientists
- Quality Managers
- Research Scientists
- Quality Analysts
- Risk Managers