Practical Guidance on Confidence Interval Evaluation in Analytical Validation
Complimentary
Learning Level: Intermediate
Time: 1000 - 1130 ET / 1600 - 1730 CET
Session Length: 90 minutes
The 2024 revision of ICH Q2(R2) marks a significant shift in analytical method validation, moving from point-based assessment toward interval-based assurance. Confidence intervals (CIs) for precision and accuracy must now be reported at an appropriate confidence level and demonstrated to be compatible with established acceptance criteria — carrying meaningful implications for how organizations design, execute, and document their validation strategies.
This webinar opens with a review of regulatory intent on statistical intervals for accuracy and precision across ICH Q2(R2), EMA, and FDA frameworks, providing participants with a clear picture of current and converging expectations. Building on this foundation, key aspects of CI implementation are examined in depth, including interpretation of CI results, underlying statistical calculations, and the establishment of scientifically justified acceptance criteria aligned with the Analytical Target Profile (ATP).
The program then addresses the practical impact of CI requirements on validation design and execution, with particular focus on how companies are applying — or considering — CIs as either formal pass/fail criteria or supportive information. Strategies for mitigation and risk assessment when a CI falls outside acceptance criteria are discussed alongside quality compliance considerations, equipping attendees with a proactive framework for navigating these scenarios in both new and legacy methods.
The webinar concludes with a series of worked examples illustrating CI calculations across a range of analytical methods and validation contexts, including complex biological assays, and features an interactive industry roundtable where regulatory alignment, submission experiences, and emerging best practices are explored.
