Kathy Gombas is a recognized food safety expert with over 30 years of experience in the food industry specializing in preventive controls, supply chain management, food safety auditing, and regulatory affairs.

Kathy retired from the U.S. Food and Drug Administration (FDA) after 10 years of service. She was a senior advisor at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). While at CFSAN, Kathy was in a leadership role supporting the agency’s Food Safety Modernization Act (FSMA) implementation efforts including the Preventive Controls Regulator Training and launch of FDA’s FSMA Technical Assistance Network for industry. Kathy also led the implementation of FDA’s Reportable Food Registry.  

Before joining FDA, Kathy held senior food safety positions at Dean Foods overseeing food safety programs for their Northeast dairy operations and then the corporate supplier management program. Prior to that, she spent 8 years at Kraft Foods conducting food safety audits worldwide and developing corporate food safety policies.

Kathy is currently a member of the Food Safety Preventive Controls Alliance (FSPCA) steering committee and co-chair for the international subcommittee working on industry training, outreach, and technical assistance programs for food companies worldwide. Finally, Kathy is on the Editorial Advisory Board of Food Safety Magazine.

Kathy graduated from Northern Arizona University with a B.Sc. in Microbiology.

In this episode of Food Safety Matters, we speak to Kathy about:

• The importance of reading and understanding FSMA guidance documents
• Highlights from the Preventive Controls Hazards Guide
• How crucial it is to get your hazard analysis right
• Remembering to look at all ingredients, including process water and overrun air, when it comes to your manufacturing process and the hazards it may present
• Being able to justify what's included--and what's not included--in your hazard analysis
• Why importers need to understand Foreign Supplier Verification Program requirements
• What FSPCA is working on next

Food Safety Magazine Articles Written and Co-Written by Kathy:
Food Safety Preventive Controls Alliance Education and Outreach Goes Global (October/November 2017)
Learning from FDA Food Allergen Recalls and Reportable Foods (April/May 2014)
The Reportable Food Registry: A Valuable New Tool for Preventing Foodborne Illness (June/July 2011)
GFSI's Role in Harmonizing Food Safety Standards (June/July 2009)
Auditing Mechanics 101: A Guide for Auditors and Auditees (April/May 2005)
Food Allergen Awareness: An FDA Priority (February/March 2001)
The Challenge of Food Allergens: An Update (October/November 2001)
Supplier Scorecards: Are They Right for You? (December 2008/January 2009)

Related Content and Resources:
Food Safety Preventive Controls Alliance
All FSMA Rules and Guidance for Industry
FDA's FSVP Importer List
FDA FSVP Guidance Document (Draft)
FSMA Guidance on Enforcement Discretion 
Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by FSMA (Draft)
HARPC Draft Guidance + Appendix 1

News Mentioned in This Episode
UPDATE: Multistate Romaine Lettuce E. coli Outbreak Continues to Spread 
VIDEO: Romaine Lettuce Farmers Frustrated by Government Response to E. coli Outbreak 
Canada Hit by Romaine Lettuce Illnesses 
USDA FSIS New Leadership Announced 
Research: Food Safety Inspection Scheduling Can Positively Impact Foodborne Illness Rates; Harvard Study 

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Madisen Hodgson, M.S. is a food safety and quality assurance professional with nearly a decade of progressive experience spanning food manufacturing, retail bakery, beverage, and airline catering environments. She currently serves as a Quality Assurance Manager for a protein and nutritional bar manufacturer in Denver, Colorado, where she oversees the full food safety management system and leads a multi-shift quality assurance team across multiple production lines.

In this episode of Food Safety Matters, we speak to WHO’s Dr. Elaine Borghi about the new global foodborne disease burden estimates, updates to the methodology, key insights from the data, and the importance of using data to target food safety interventions, aligning with the WFSD theme “From Burden to Solutions—Safe Food Everywhere.”

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Brady Carter, Ph.D. is the Chief Scientific Officer at Carter Scientific Solutions. He specializes in water activity, moisture sorption, shelf-life stability, plant science, and wheat production and quality. He has 23 years of experience in research and development and previously was a Research Professor at Washington State University focusing on wheat end-use quality. Dr. Carter has pioneered work in using dynamic isotherms to investigate product stability and establish critical water activities for optimal shelf life. He also specializes in shelf-life loss and effective utilization of instrumentation to address product safety and quality issues. Dr. Carter holds a Ph.D. in Crop Science and Food Engineering and an M.S degree in Cereal Chemistry and Crop Science from Washington State University, as well as a B.A. degree in Botany from Weber State University.