Test method development is a systematic, iterative process to ensure analytical methods are scientifically sound. Once developed, methods undergo rigorous validation to confirm they are reliable, reproducible, and suitable for their intended purpose. A validated method must consistently produce accurate and precise results within set performance limits.
In regulated environments, validated methods support compliance decisions, guided by decision rules—criteria that determine if results meet specifications. These decisions must account for measurement uncertainty, which defines confidence in reported values and establishes statistical result boundaries.
This course introduces participants to two method validation processes, exploring their applications, strengths, and regulatory considerations. It also covers approaches for estimating measurement uncertainty, essential for regulatory compliance.
Participants will learn about a harmonized, guided validation pathway integrated with a digital platform for uncertainty determination. This tool automates expanded uncertainty calculations using key validation parameters, offering a streamlined, compliant process from development to reporting.
The course goes beyond theory, equipping attendees with practical tools and methods ready for immediate use in laboratory settings.
