EP Framework: Validation Studies and Data Review

Discover the latest in laboratory and diagnostic innovation with a new half-day virtual event from CLSI. This unique training session features keynote and panelist discussions with prominent industry experts and regulatory authorities as well as applied learning labs and workshop discussions. Sessions cover foundational statistical techniques and testing protocols to quality system implementation essential and standards conformance. Discuss real world challenges, anticipated oversight, and how the new regulatory implications will affect your laboratory with those who are in it every day! 

In this session, apply evaluation protocols to establish analytical performance.

Learning Objectives

1. Describe the key principles of the Evaluation Protocol (EP) framework and its application to test validation across various contexts.

2. Apply the Test Life Phases Model for assessing analytical performance and ensuring robust validation studies during the establishment stage of test development. 

3. Identify key strategies for reviewing data to evaluate a test method’s analytical performance.