Summary
Regulatory guidance underpinning analytical method development and validation is changing. Regulators are now emphasising a Quality by Design (QbD) approach to analytical methods that supports their suitability for use over their entire life cycle. New draft ICH guidances on method development and validation (ICH Q14 and ICH Q2 respectively) were published for consultation in March 2022. The purpose of this course is to set out these new guidances in the context of other compendial and regulatory agency expectations and to help attendees avoid common mistakes during the development and validation of test methods, whether for biological or chemical drugs. Key concepts such as the Analytical Target Profile (ATP) and Analytical Control Strategy (ACS) will be explained with examples. Test methods often lack robustness because of poor documentation, which can lead to errors or high variability during routine use or method transfer. A risk-based approach to method documentation is included in the course. Each day will conclude with a workshop that will give participants the opportunity to put into practice what they have learned.
Learning Objectives
- Update on current regulatory expectations
- How to write an effective ATP
- How to set meaningful system suitability criteria as part of the overall ACS
- Writing method validation, verification and transfer protocols and setting appropriate acceptance criteria
- Allowable changes to compendial chromatographic methods
- Parameter-specific validation acceptance criteria and system suitability limits (e.g., elemental impurities and residual solvents)
- How to avoid common errors in test method documentation
- Dealing with method validation failure
Key Topics
- Life cycle management of analytical methods
- USP <1220> – Analytical Procedure Life Cycle
- ICH Q14 – Analytical Procedure Development
- ICH Q2 (R2) – Validation of Analytical Procedures
- Options for test method qualification (validation, verification and transfer)
- US FDA and EMA expectations for test method validation, execution and documentation
- Compendial guidance on allowable changes to chromatographic methods
- Deriving method validation acceptance criteria from the ATP
- Important elements of the ACS
- A risk-based approach to test method documentation
- Designing suitable method validation, verification and transfer experiments
Who should attend?
Analytical Development Scientists, Quality Control Personnel, Quality Assurance Professionals, Regulatory Affairs Specialists, Project Managers, Consultants
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainer
