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 (http://www.globalharmonization.net/), 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. (http://www.foodsafetyprofessionals.com/)—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.

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

Related Content and Resources: Quality Management Systems - Process Validation Guidance by SG3, 2nd Edition, 2004 (see decision tree on pg. 6) http://bit.ly/2CFUslO

Larry Keener's Articles Published in Food Safety Magazine: COVER STORY: Key New (and Not So New) Food Safety Challenges (December 2017/January 2018) http://bit.ly/2Aw9Dlg Risks of Oligodynamic Silver Use in Food Preservation and Processing Operations (June/July 2017) http://bit.ly/Oligodynamic Novel Food Safety Technologies Emerge in Food Production (Feb/March 2015) http://www.foodsafetymagazine.com/magazine-archive1/februarymarch-2015/novel-food-safety-technologies-emerge-in-food-production/ Shedding Light on Food Safety: Applications of Pulsed Light Processing (June/July 2014) http://www.foodsafetymagazine.com/magazine-archive1/junejuly-2014/shedding-light-on-food-safety-applications-of-pulsed-light-processing The Squeaky Wheel: Is Transportation the Watershed for Food Safety and Food Defense? (Aug/Sep 2013) http://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2013/the-squeaky-wheel-is-transporation-the-watershed-for-food-safety-and-food-defense/ Ex Ante or Ex Post Food Safety Strategies: Process Validation versus Inspection and Testing (June/July 2011) http://www.foodsafetymagazine.com/magazine-archive1/junejuly-2011/ex-ante-or-ex-post-food-safety-strategies-process-validation-versus-inspection-and-testing/ Hurdling New Technology Challenges: Investing in Process Validation of Novel Technologies (Feb/March 2006) http://www.foodsafetymagazine.com/magazine-archive1/februarymarch-2006/hurdling-new-technology-challenges-investing-in-process-validation-of-novel-technologies/ Looking for more by Larry Keener? Search FoodSafetyMagazine.com https://www.foodsafetymagazine.com/?Keywords=larry+keener&display=search&newSearch=true&noCache=1

News Mentioned in This Episode Feb. 22 Update | Listeria Outbreak in South Africa | National Institute for Communicable Diseases http://bit.ly/2opgcNv Fiscal Year 2019 Budget http://bit.ly/2okgO7X Various Dog Foods Recalled for Salmonella, Listeria and Presence of Illegal Drug http://bit.ly/2oat1Mo Additional info on dog food recalls by company/brand:  Smokehouse Pet Products http://bit.ly/2GB5qLy,  Raws for Paws http://bit.ly/2CCoIh9,  Redbarn Pet Products http://bit.ly/2okaI7p,  Arrow Reliance Inc. (Darwin's Natural and ZooLogics) http://bit.ly/2HDYFtC,  J.M. Smucker (Gravy Train and Kibbles 'N Bits) http://bit.ly/2HDZbrB

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