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How to Design and Conduct Challenge Studies for Safer Products and Longer Shelf Life

Start Date: 6/26/2025
Start Time: 2:00 PM EDT
Duration: 60 minutes

Abstract

Defining the objective of a challenge study may be less straightforward than it may appear initially. The two types of challenge studies are pathogen growth inhibition and pathogen inactivation. It is possible that your product may need both studies conducted. The choice of target pathogen(s), inoculation method, inoculation level, temperature(s) tested, and controls will vary depending on the study objective(s). Can you find "safe harbors" in regulations, validated predictive models, or published literature that sufficiently match your product to substitute for a challenge study, or will you be able to reduce the number of experiments needed for validation? Our expert speakers from the Food Research Institute (FRI) at the University of Wisconsin–Madison will answer these questions and more, in this webinar discussing the "why" and "how" of conducting challenge studies to ensure safer food products and longer shelf life.

From this webinar, attendees will learn:
  • Information needed before designing a challenge study
  • How to conduct challenge studies for microbial spoilage and pathogen growth, including the common challenges encountered, laboratory selection, and use of predictive models
  • How to interpret and apply the results of a challenge study

Speakers

Kathleen Glass, Ph.D.

Associate Director, Food Research Institute (FRI)

University of Wisconsin–Madison

Kathleen Glass, Ph.D. is Emeritus Associate Director and Distinguished Scientist for the Food Research Institute (FRI) at the University of Wisconsin–Madison. Prior to her retirement in January 2025, she worked with the food industry and regulatory agencies to evaluate microbial food safety risks, and design and conduct microbial food challenge studies to identify critical control limits for production. She was a four-term member of the National Advisory Committee for the Microbiological Criteria for Foods (NACMCF) that wrote the inoculated pack study guidelines and taught the International Association for Food Protection (IAFP) Challenge study workshop from 2011 until 2023.

Kristin Schill, Ph.D.

Assistant Research Professor, FRI

University of Wisconsin–Madison

Kristin Schill, Ph.D. is a Research Assistant Professor at the University of Wisconsin–Madison's Food Research Institute (FRI) and leads the Applied Food Safety Laboratory. In this capacity, Kristin works directly with the food industry to design food challenge studies on a wide variety of food products and for foodborne pathogens including Clostridium botulinum, Clostridium perfringens, Listeria monocytogenes, Bacillus cereus, Staphylococcus aureus, and other gram-negative pathogens. Prior to joining FRI, Kristin served as a research microbiologist for the Food and Drug Administration. Dr. Schill is a member of the International Association for Food Protection (IAFP) and co-teaches the IAFP Sponsored Microbial Challenge Testing for Foods Workshop. She also serves on the National Advisory Committee for the Microbiological Criteria for Foods (2023–2025).

Cynthia Austin, Ph.D.

BSL-2 Lab Manager, Meat Science and Animal Biologics Discovery, FRI

University of Wisconsin–Madison

Cynthia Austin, M.S. is the Lab Manager for the Biosafety Level 2 (BSL-2) meat processing laboratory at the Meat Science and Animal Biologics Discovery (MSABD) Building at the University of Wisconsin–Madison. In her role, she works with meat companies to design and perform microbiological studies to help ensure safe meat products. Prior to joining UW, she worked for nearly 17 years in Oscar Mayer's Corporate Food Safety Department.

Adrienne Blume, M.A. (Moderator)

Editorial Director

Food Safety Magazine

Adrienne Blume is Editorial Director of Food Safety Magazine, a BNP Media brand. She has 18+ years of experience in B2B technical media, including the food safety and quality (FSQ) and energy technology sectors. She manages the editorial content for Food Safety Magazine and its podcast, Food Safety Matters, and also serves on the Educational Advisory Board for the annual Food Safety Summit. She keeps a pulse on trends, issues, and regulatory developments in FSQA by attending and moderating sessions at food industry and food safety conferences worldwide. Previously in her career, Ms. Blume launched and led two energy technology publications (H2Tech and Gas Processing & LNG) and a podcast (H2TechTalk) as Editor-in-Chief at Gulf Energy Information in Houston, Texas. She also worked as Managing Editor at Hydrocarbon Publishing Company in Philadelphia, Pennsylvania. She speaks and moderates at technical conferences around the world and is published in several industry journals. Ms. Blume holds an M.A. degree in English and Publishing from Rosemont College in Rosemont, Pennsylvania, as well as B.A. degrees (hons) in English and Anthropology from Webster University in St. Louis, Missouri.



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