Analytical Quality by Design: Critical Analytical Procedure Parameters and Risk Assessments
Key Learning Outcomes
- Understand what Critical Method Parameters (CMPs) are, how they relate to the Analytical Target Profile under ICH Q14’s enhanced approach, and why a systematic framework for identifying them is essential for sound method development.
- Learn how fishbone diagrams and risk assessments offer a structured, repeatable way to capture SME knowledge, map method inputs, and rank parameters by their potential impact and risk on analytical performance.
- Discover how prior knowledge can be formally integrated into the risk assessment process, reducing redundant effort across projects and creating a reusable knowledge base for each analytical technology platform.
- Explore how risk scoring, criticality ranking, and mitigation planning work together to guide development decisions, including when targeted experiments are needed to validate or challenge a parameter’s assigned risk level.
Event Overview
This webinar by Dr Cyrille Chéry introduces Critical Method Parameters and risk assessment within the ICH Q14 enhanced approach, providing a practical and grounded perspective on shifting from intuitive method understanding to a documented, systematic development process. The presentation starts by defining CMPs, which are parameters that, if not followed, can result in failure to meet the Analytical Target Profile, and places them within the ICH Q14 framework, particularly in the risk management phase after technology selection.
Using real-world examples from ICP-MS and size-exclusion chromatography, the session demonstrates how method parameters such as sample pH and UV wavelength can directly influence ATP compliance and why assumptions alone are not enough without a structured process for identification and ranking. Cyrille will clarify how the fishbone analysis across six dimensions (method, material, measurement, environment, manpower, and instruments) translates into a practical risk assessment table with clear low-to-high scores that any team can use, regardless of the project phase.
A key theme throughout is the importance of prior knowledge: how it can be recorded once, reused across projects, and refined as understanding develops during the development process. The session also tackles a common misconception that the enhanced approach requires significant extra resources and shows how targeted experiments and simple documentation in a laboratory notebook can fully meet the aims of the framework.
Who Should Attend?
Anyone involved in analytical method development or quality strategy seeking to adopt a practical, risk-based approach to identifying and managing Critical Method Parameters in accordance with ICH Q14.
- Analytical Scientists and Method Development Chemists
- Quality Control and Quality Assurance Professionals
- Regulatory Affairs and CMC Submission Specialists
- Biopharmaceutical and Small Molecule Development Teams
- Validation and Compliance Scientists
- R&D and Technical Operations Managers overseeing analytical functions
Unlock Additional Educational Resources
Register today for Cyrille’s presentation and gain access to exclusive bonus content, such as the insightful panel discussions on “Overview of the ICH Q14 Guideline” and “Key Challenges and Solutions in Implementing ICH Q14”.
Dr Cyrille ChéryAssociate DirectorUCB (Belgium)Dr Cyrille Chéry is the Associate Director at UCB, a Belgian pharmaceutical company. He leads the team responsible for developing and validating analytical methods for controlling drug substances and drug products (NCEs and antibodies). These methods utilise physicochemical principles, such as mass spectrometry. He holds a PhD (2004) in analytical chemistry from the University of Ghent, Belgium, and a Master of Science (1997) from the University of Bordeaux. Before joining UCB in 2012, he held various positions in analytical chemistry at MSD/Merck, focusing on small molecules (new chemical entities). He is the author of papers on inductively coupled plasma-mass spectrometry and on analytical quality by design.
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