Food Safety Matters

Ep. 26. Kathy Gombas: FSMA Guidance

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.

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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)

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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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Author(s): Staff