Statistical Considerations for ICH Guidelines 2014

  • 04-05 Aug 2014
  • Hilton Sydney, Australia

Description

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

Past Events

Important

Please, check "Statistical Considerations for ICH Guidelines" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance, Quality assurance
Health & Medicine: Healthcare, Medical device, Medical laboratories, Pharma
Industry: Food & Beverages

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions