Ep. 20. Larry Keener: Validation Before Verification

Larry Keener has a long record of involvement, both nationally and internationally, with food industry issues. He is the current vice president and co-chair of the Austrian-based Global Harmonization Initiative, an organization founded in 2004 to promote harmonization of food safety legislation and regulations. He is president and chief executive officer of Seattle-based International Product Safety Consultants, Inc.—a global leader in providing food safety and food technology solutions to the food processing industry for a broad client base of Fortune 500 food companies, academic research institutes, and government agencies. Also, Larry has written and published more than 100 scientific papers and numerous book chapters on food safety, microbiology, and process validation. He is a frequently invited speaker to the food industry, business and scientific conferences, workshops, and seminars.

Larry is an internationally regarded microbiologist and process authority in the food industry, and frequently works with food companies in this capacity to communicate the processor's regulatory responsibilities, assess risk and adequacy of controls for entire processing operations from raw materials receipt to finished product storage and distribution, and provide advice and direction with regard to regulatory impact and food safety risk that changes in operations might cause. As such, his areas of expertise range from applied food microbiology and sanitation methods, the development and application of thermal and non-thermal processing and preservation technologies, including high-pressure processing, microwave and pulsed electric field, high-powered ultrasound and design and implementation of food safety management and control systems and strategies.

Finally, Food Safety Magazine is proud to have Larry as a member of our editorial advisory board.

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In this episode of Food Safety Matters, we speak to Larry once again about:

Why the concept of validation causes so much confusion for both regulators and food safety professionals
The reason why validation and verification are not interchangeable terms
Verification by way of end product testing
How the process of validation has evolved over the years
How FSMA and HARPC have changed the validation process
Why FDA decided to build validation requirements and HARPC into new FSMA rules
Whether there really is a difference between HACCP and HARPC
Types of validation: prospective, concurrent and retrospective
The reason why concurrent validation is so often overlooked
The importance of validation when changing or reformulating a food product's manufacturing process
Examples of how food spoilage was the result of not validating a new process
The use of a multidisciplinary team to properly perform validation
HACCP decision trees vs. validation decision trees

News Mentioned in This Episode
Feb. 22 Update | Listeria Outbreak in South Africa | National Institute for Communicable Diseases
Fiscal Year 2019 Budget
Various Dog Foods Recalled for Salmonella, Listeria and Presence of Illegal Drug

Additional info on dog food recalls by company/brand: Smokehouse Pet Products, Raws for Paws, Redbarn Pet Products, Arrow Reliance Inc. (Darwin's Natural and ZooLogics), J.M. Smucker (Gravy Train and Kibbles 'N Bits)

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Author(s): Staff