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.

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) http://bit.ly/2x7V4hR
Learning from FDA Food Allergen Recalls and Reportable Foods (April/May 2014) http://bit.ly/2KzsSuE
The Reportable Food Registry: A Valuable New Tool for Preventing Foodborne Illness (June/July 2011) http://bit.ly/2Gvtejn
GFSI's Role in Harmonizing Food Safety Standards (June/July 2009) http://bit.ly/2rRHYE9
Auditing Mechanics 101: A Guide for Auditors and Auditees (April/May 2005) http://bit.ly/2GukD0E
Food Allergen Awareness: An FDA Priority (February/March 2001) http://bit.ly/2IsN5WA
The Challenge of Food Allergens: An Update (October/November 2001) http://bit.ly/2Iwl5NJ
Supplier Scorecards: Are They Right for You? (December 2008/January 2009) http://bit.ly/2k97gtQ

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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