IEH Academy Webinar

Regulatory Status of Test Methods: Does FDA Approve Your Test Method?

Curious if your microbiological testing methods align with FDA standards? Join us for a comprehensive overview of FDA guidelines regarding microbiological testing in the food industry.

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Webinar Recording

Description

Topics of discussion include the criteria for test methods to meet FDA standards, the relationship between FDA guidelines and AOAC in method selection, and the circumstances under which FDA-validated methods are required against specific FDA methods. By applying FDA insights, attendees will enhance their microbiological testing methods and food safety programs, allowing them to navigate the regulatory landscape with confidence.

Topics Covered

Overview of FDA method validation guidelines
Implementation of FDA expectations in industry practices
The relationship between the FDA and AOAC
Circumstances where the FDA mandates methods validated against specific standards

Who Should Attend

Food safety professionals seeking regulatory insights
Quality assurance personnel involved in microbiological testing
Professionals conducting microbiological testing for food and environmental surfaces
Industry stakeholders determining suitable microbiological testing methods

Webinar Length

1 hour with Q&A to follow.

The webinar will include a 10-minute Q&A session where attendees can ask questions related to managing consumer complaints. This interactive portion is designed to offer personalized guidance and facilitate the sharing of practical insights among participants.

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Meet the Instructor

Thomas Hammack

Thomas Hammack joined IEH as Vice President of Technical Services in 2024. He has over 30 years of experience in the field of food microbiology, working at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Starting in 1990, he began his tenure at the FDA as a research microbiologist until he became the Chief of the Microbial Methods Development Branch (MMDB) in 2009. In this role, he led a team of 25 microbiologists in developing and validating methods for the detection and characterization of bacterial pathogens and toxins in foods and on environmental surfaces. After a decade as Chief of MMDB, he concluded his tenure as a Senior Policy Analyst for Microbiology in CFSAN’s Office of Regulatory Science.

He is a co-author of FDA’s Bacteriological Analytical Manual’s (BAM) Salmonella, Cronobacter, and Food Sampling and Preparation of Sample Homogenate chapters. During his career, he Chaired the FDA’s Microbiology Methods Validation Subcommittee (MMVS) from 2017 to 2021, which oversees the validation of the microbiological methods used in the FDA’s Foods Program. He also chaired the FDA’s Bacteriological Analytical Manual (BAM) Council from 2009 to 2016. He remained a member of both the BAM Council and MMVS until his retirement at the end of 2023.

Thomas Hammack’s expertise extends beyond his roles at the FDA. He currently serves as an Expert Review Panel member for AOAC International, overseeing the validation of numerous methods for bacterial pathogens, including Salmonella, Listeria, and E. coli O157:H7. Since 2014, he has been a dedicated member of the MicroVal Technical Review Committee. Notably, he served as the Chair of the US Technical Advisory Group to ISO TC 34/SC 9 from 2011 to 2023, the committee responsible for the development of all ISO food microbiological methods.

Carol Cave

Ms. Carol Cave joined IEH as the Executive Vice President in 2024, bringing with her extensive expertise in regulatory affairs and consumer protection. She holds a B.S. in Consumer Economics from the University of Maryland.

Before joining IEH, Ms. Cave served as the Acting Associate Commissioner (ACRA) for the Office of Regulatory Affairs (ORA) at the Food and Drug Administration. In this role, she oversaw approximately 5000 ORA employees stationed across the U.S. and around the world.

Prior to her role as Acting ACRA, Ms. Cave served as Deputy Associate Commissioner, where she managed inspections, compliance, enforcement, field laboratory operations, import operations, and strategic planning.

Earlier in her career at the FDA, she served as the Assistant Commissioner of Import Operations, where she led the Office of Enforcement and Import Operations, ensuring FDA-regulated imported products comply with U.S. laws. Ms. Cave also led coordination efforts between the FDA and U.S. Customs and Border Protection, developing joint regulations, policies, procedures, and operations.

Before her tenure at the FDA, Ms. Cave was the Deputy Director of the Office of Compliance and Field Operations at the U.S. Consumer Product Safety Commission (CPSC). In this role, she collaborated with federal government agencies to identify potentially defective consumer products. With nearly 26 years at the CPSC, Ms. Cave held various leadership positions, including Director of State and Local Programs and Assistant Executive Director for the Office of Import Surveillance, ensuring the safety of consumer products nationwide.

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