CLM - 503 Method Comparison & Process Validation

This course is designed to prepare laboratory professionals to understand the principles and procedures used to verify manufacturer’s claims of analytical performance for in vitro diagnostic products. Determining if total allowable error is exceeded will be emphasized. Topics include: compliance with proficiency testing requirements, validation of reference ranges, determination of decision cut-off points, and both quantitative and qualitative method evaluation. Offered: Spring. Retake Counts for Credit: No. Pass/No Pass Grading Allowed: No. Credit(s): 3