AOAC-03 Preliminary Program

SCIENTIFIC SESSIONS

SUNDAY, SEPTEMBER 18, 2016 8:30 am – 12:00 pm

The workshop will be given in the following parts. Part I The test method will be a quantitative method used from the Limit of Quantitation to a high concentration. The acceptance criteria will be given. This means the following performance characteristics need to be included in the method validation: selectivity, linearity, trueness (bias) (accuracy), repeatability, intermediate precision, limit of detection, limit of quantitation, measurement uncertainty. The test method will be presented and then the attendees will discuss what they would validate and how. They will design the experiments to be performed for the method validation. Part II The experiments and statistical tools for evaluating the experiments for the case study will be presented. Part III The DOE (ANOVA), or AOAC ruggedness test, or simplex DOE will be presented. Part IV The experimental results will be compared to the acceptance criteria. A brief method validation report will be presented. An EXCEL spreadsheet will be distributed to the attendees. These EXCEL files will be used, so the attendees should bring their own laptops to the workshop. CO-CHAIR: Jane Weitzel, Consultant CO-CHAIR: Franz Ulberth, European Commission - Institute for Reference Materials and Measurements • Jane Weitzel, Independent Consultant Part I Introduction to the Case Study • Franz Ulberth, European Commission - JRC - IRMM Part II Experiments and Statistical Evaluation for Method Validation • Susan Audino, Audino & Associates, LLC Part III Simplex Experiments for Method Validation • Jane Weitzel, Independent Consultant Part IV The Method Validation Report

Statistics Committee Workshop: Data Analysis for Microbiological Method Validation Studies This workshop will explain and teach participants the statistical data analyses used in microbiological method validation studies as required by AOAC Guidelines Appendix J. Appendix J was adopted in 2012 as the guideline for validating AOAC OMA and PTM methods for microbiological analytes. The workshop will cover procedures and software used for both qualitative and quantitative methods for single-lab and multi-lab studies. The workshop will be targeted for method developers, kit manufacturers, ERP members, method reviewers, and method users. New and improved statistical workbooks will be introduced and demonstrated at this workshop. CHAIR: Paul Wehling, Medallion Laboratories/ General Mills • Paul Wehling, Medallion Laboratories/ General Mills • Sharon Brunelle, AOAC Technical Consultant • Maria Nelson, AOAC Technical Consultant TDLM Training Session: Method Validation and Statistics—A Case Study This workshop will explain the basic statistics necessary for method validation such as regression analysis, ANOVA for precision estimation, and Design of Experiments (DOE). There are many guides and there have been many training sessions on method validation. This workshop will build on these by presenting a completed method validation for a specific case. The HOW TO use statistics when validating a method will be presented and emphasized. 1:00 pm – 4:30 pm

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September 18–21, 2016

Sheraton Hotel, Dallas, Texas