ICH Q2/Q14 Analytical Procedure Life Cycle Management

This conference provides a comprehensive overview of the new ICH Quality Guideline Q14 on Analytical Procedure Development, and the revised Q2 Guideline on Validation of Analytical Procedures. Experts from authorities, industry and contract laboratories will discuss with you the contents, their significance for practice and approaches for implementation in your company.

Highlights

  • Regulatory Developments and Expectations
  • ƒ Compendial vs. Modern Approaches
  • ƒ Analytical Target Profile (ATP)
  • ƒ Validation for MAA/NDA
  • ƒ ECA Guide for APLM
  • ƒ Robustness and DoE
  • ƒ Control Strategy

Chromicent is pleased to present a lecture on “How Software Tools can Support QbD Method Development”.

Keywords:

  • Modern Quality-by-Design approach
  • ƒ Statistical concepts with experimental design plans (also referred to as Design-of-Experiments) as an efficient and fast tool for method development
  • ƒ Multivariate data analysis software package Fusion QbD®
  • ƒ Chromatography simulation software DryLab®
  • ƒ Workflow and examples in using software packages for method development

For further information please follow the link – or download