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September 18–21, 2016
Sheraton Hotel, Dallas, Texas
14
SUNDAY, SEPTEMBER 18, 2016
8:30 am – 12:00 pm
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
1:00 pm – 4:30 pm
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.
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
SCIENTIFIC
SESSIONS