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Method Validation and Statistics for Microbiological Methods-Part A: Qualit...

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Joint Institute for Food Safety and Applied Nutrition (JIFSAN)

University of Maryland

5145 Campus Drive Patapsco Building, Suite 2134

College Park, MD 20742-6730

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Description

Method Validation and Statistics for Microbiological Methods:
Part A – Qualitative Methods

How reliable are your results?


Training Workshop Series

Part A: Validation of Qualitative Microbiological Methods

Course Topics Include:

  • Statistics for qualitative microbiological methods (e.g. culture-based, immunoassay-based, and molecular)
  • Performance standards for qualitative microbiological methods: Scientific basis and how to interpret
  • Validation pathways and approaches for qualitative methods (ISO 16140 series and AOAC protocol)
  • Examples of single laboratory and multi-laboratory validation studies for qualitative methods


Course Description

With the increasing number of microbiological methods available from the industry and regulatory agencies for many different purposes, there is an increasing need for validation of the methods with regards to experimental design, data analysis, performance evaluation, and competence determination. A comprehensive training curriculum on microbiological method validation has been developed primarily for training scientific staff in the field of microbiology in testing laboratories, industry and regulatory laboratories. This training course is the first part of a series of courses, aimed at qualitative microbiological methods i.e. methods which detect presence or absence of analyte in a test portion. The 3-day training course aims to provide scientists with the understanding of terminologies and principles used in national and international validation standards, and ability to design, conduct and evaluate single lab and multi lab method validation studies. The training course also aims to provide scientists with skills to interpret validation performance characteristics in order to establish quality control measures and make decisions on the use of appropriate microbiological method. This workshop and curriculum have been developed by QuoData GmbH and will be conducted by experienced team in method validation from QuoData GmbH, along with experts in microbiology, food safety and compliance from IFSH and FDA.


Who Should Attend

This course is intended for microbiologists, molecular biologists, food safety specialists, scientific staff of analytical and microbiological testing laboratories, management personnel from industry, officials from national and state regulatory bodies, among other interested parties from agriculture, food, and beverage industries.

This course will specifically benefit individuals who want to:

  • design, conduct and perform single or multi-laboratory validation study of an existing or a newly developed proprietary qualitative method
  • evaluate, analyze and interpret the results of a microbiological detection method


Learning Objectives

This 3-day intensive training course is intended for participants to enhance their skills and understanding in establishing the performance of the qualitative method used for detection of mircobes in food samples. Main learning goals can be summarized as -

  • Understand the terminology of national and international validation standards (AOAC, ISO 16140)
  • Design, conduct and evaluate single or multi-laboratory method validation studies
  • Utilize the validation performance characteristics in order to make decisions regarding the appropriate use of microbiological methods
  • Make use of validation performance characteristics in order to establish quality control instruments
  • Optimize testing strategies


Workshop Leaders and Delivery Style

The course will be presented by leaders in method validation from QuoData GmbH, along with microbiology experts and food safety officials from IFSH, FDA and IIT Chicago. Together, they are highly qualified, trained and experienced in international standards for establishing performance characteristics, and microbiological methods for foods. Interactive presentations and discussions will be held, with examples detailing the different scenarios, approaches, and calculation steps. A curriculum book will be provided to the participants.


Agenda Outline

Chapter 1 | Preface and Introduction | Day 1, 0.5 hour

Chapter 2 | A primer on statistical concepts for non-statisticians useful for qualitative microbiological methods –

Poisson distribution, confidence intervals, McNemar test and MPN methods. | Day 1, 3 hours

Chapter 3 | How to establish the scientific and statistical basis for developing performance criteria for validation of qualitative microbiological methods, according to ISO 16140 and AOAC standards. | Day 1, 2 hours

Understanding the performance characteristics including LOD, sensitivity, specificity and reproducibility through relevant examples from food microbiology. | Day 1 , 1 hour and Day 2, 1 hour

Chapter 4 | What are the strategies for validation of methods based on your goal for performance assessment and scope of the method.| Day 2, 1 hour

Discussion on validation pipelines, guidance on selection of appropriate assessment workflow using decision trees.| Day 2, 2 hours

Chapter 5 | Illustrative examples on how to perform a validation study for microbiological methods - from inception to completion. Step-by-step procedure using Excel tools for conventional single laboratory study. | Day 2, 3 hours

Detailed calculation steps, using simple spreadsheet (MS Excel) tools for Factorial Single-laboratory Validation study and conventional multi-laboratory validation study. Overview of factorial multi-laboratory validation study. | Day 3, 6.5 hours


Training course and curriculum developed and conducted by QuoData GmbH and FDA, under the aegis of IFSH/IIT.


Directed by:

  • Ravinder Reddy, Ph.D., Senior Microbiologist, FDA
  • Jason Wan, Ph.D., Professor, IIT
  • PD Dr. habil. Steffen Uhlig, QuoData GmbH


Each person receives a Workbook, Software, Certificate of Completion.


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Date and Time

Location

Joint Institute for Food Safety and Applied Nutrition (JIFSAN)

University of Maryland

5145 Campus Drive Patapsco Building, Suite 2134

College Park, MD 20742-6730

View Map

Refund Policy

No Refunds

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