FAM Expert Review Panel (ERP) Training

Review of MLV Validation Protocols • Data Submission – a data report form is highly recommended to ensure capture of all relevant information for all analyses • Name of laboratory • Name of analyst

• Date(s) of analysis • Equipment used • Critical reagents/supplies documented (catalog #, lot#) • Calibration curve(s) • Raw data • Calculated results • Critical parameters (e.g., dilution factor) • Protocol or method deviations • Data QC-checked?

23

Review of MLV Validation Protocols

• Data Analysis • Are all appropriate method performance parameters identified and defined? • Are equations correctly presented? • Is an appropriate and current AOAC Statistical Workbook available and cited? • Are acceptance criteria from SMPR clearly stated, if applicable?

24