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.

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)

Larry Keener's Articles Published in 
Food Safety Magazine:
COVER STORY: Key New (and Not So New) Food Safety Challenges (December 2017/January 2018)
Risks of Oligodynamic Silver Use in Food Preservation and Processing Operations (June/July 2017)
Novel Food Safety Technologies Emerge in Food Production (Feb/March 2015)
Shedding Light on Food Safety: Applications of Pulsed Light Processing (June/July 2014)
The Squeaky Wheel: Is Transportation the Watershed for Food Safety and Food Defense? (Aug/Sep 2013) 
Ex Ante or Ex Post Food Safety Strategies: Process Validation versus Inspection and Testing (June/July 2011)
Hurdling New Technology Challenges: Investing in Process Validation of Novel Technologies (Feb/March 2006)

Looking for more by Larry Keener? Search FoodSafetyMagazine.com

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)

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.”

Alissa Welsher, Ph.D. is a Senior Consultant at Elanco Poultry Food Safety. Dr. Welsher received her bachelor's degree in biological sciences from the University of Pittsburgh, a master's degree in poultry science, and a Ph.D. in cell and molecular biology from the University of Arkansas. Her area of expertise is in meat and poultry food safety, and she specializes in integrated pest management (IPM). 

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.

To get a taste of the discussions that were happening at the 2026 Food Safety Summit, we spoke face-to-face with Roberta Wagner, M.Sc., Senior Vice President of Regulatory and Scientific Affairs for the International Dairy Foods Association (IDFA); Steven Mandernach, J.D., Executive Director of the Association of Food and Drug Officials (AFDO) and Sandra Eskin, J.D., CEO of STOP Foodborne Illness; Jacob Nelson, Asset Protection Sales Manager at the Sherwin-Williams Company and Feraas Aiameh, Food and Beverage Marketing Manager at the Sherwin-Williams Company; Conrad Choiniere, Ph.D., Director of  the U.S. Food and Drug Administration’s (FDA's) Office of Microbiological Food Safety, Vanessa Coffman, Ph.D., Director of the Alliance to Stop Foodborne Illness, and Lone Jespersen, Ph.D., Founder and Principal of Cultivate SA; and Cindy Jiang, Senior Director, Global Food Safety Risk Management, Global Supply Chain at McDonald's (retired).

To get a taste of the discussions that were happening at the 2026 Food Safety Summit, we spoke face-to-face with Jeremy Zenlea, M.B.A., Vice President and Head of Health and Safety for EG America and Laurie Farmer, Director of the U.S. Food and Drug Administration’s (FDA’s) Office of Retail Food Protection; David Clifford, M.B.A., Director of Food Safety at Nestlé USA and Sara Mortimore, M.Sc., Founder of Sara Mortimore LLC and formerly Vice President for Food Safety at Walmart; Frank Curto, Ph.D., Vice President of Operations at Ecowize North America; and Drew McDonald, Senior Vice President of Quality, Food Safety, and Regulatory Affairs for Taylor Fresh Foods and Conrad Choiniere, Ph.D., Director of FDA’s Office of Microbiological Food Safety.

Larry Keener, CFS, PA is President and CEO of International Product Safety Consultants Inc. and an internationally regarded microbiologist and process authority in the food industry. His areas of expertise range from applied food microbiology to the development and application of novel preservation technologies.