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)

Chris McGarvey is the Director of the Regulatory and Compliance Team for Walker Morris LLP in the UK. He has more than 25 years of experience working in both the private and public sector, and has a track record of helping clients navigate complex legal challenges in areas of highly regulated economic activity. Chris specializes in food law and led the Food Standards Agency's (FSA's) Legal Team through Brexit, the COVID-19 pandemic, and supply chain challenges associated with the Ukraine conflict. Chris' typical clients are Directors, Senior Managers, and specialists, particularly food scientists, who demand quick, accessible, and accurate advice. His work often has national reach and spans all four nations of the UK.

Kye Luker serves as the Chief Product Officer at FlexXray, where he leads development of the company's innovative X-ray inspection process and technology. With more than two decades of experience in the service, consumer packaged goods (CPG), and food and beverage industries, Kye brings a wealth of knowledge in continuous improvement, quality assurance, and formulations to his role.

Richard (Rick) Stier, M.S. is a consulting food scientist who has helped food processors develop safety, quality, and sanitation programs. He believes in emphasizing the importance of how these programs can help companies increase profits. Rick comes from a family background in food science, with the Institute of Food Technologists (IFT) establishing an award in his mother's name—the Humanitarian Award for Service to the Science of Food in honor of Elizabeth Fleming Stier. Rick holds degrees in food science from Rutgers University and the University of California at Davis. He is also a member of the Editorial Advisory Board of Food Safety Magazine.

Claire Sand, Ph.D. is a global packaging leader with 40 years of experience in food science and packaging. As founder of Packaging Technology and Research LLC, her mission is to enable a more sustainable food system by advancing innovations that extend food shelf life and reduce waste.

Dr. Sand specializes in leading cross-functional teams, developing technology strategies, and creating implementation roadmaps for complex packaging challenges across the value chain. With over 150 publications to her credit, she is a regular contributor to leading food science and packaging publications and has held adjunct faculty positions at Michigan State University and California Polytechnic State University.

Kathleen Sanzo, J.D. is Co-Chair of Morgan Lewis' life sciences industry team. She centers her practice on regulatory and compliance issues connected to U.S. Food and Drug Administration (FDA)-regulated products. She leads and counsels clients on all legal and regulatory issues concerning food, dietary supplements, and cosmetic product manufacture, approval, marketing, and distribution; food, drug, and device compliance and enforcement matters; and consumer product issues regulated by the U.S. Consumer Product Safety Commission and state enforcement agencies, among other areas. A frequent author and co-author on publications related to FDA matters, Kathleen regularly speaks on these issues at industry events. She serves as Vice Chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice, and is a member of the Food and Drug Law Institute's Medical Products Committee.

Campbell Mitchell, M.B.A. is Head of Food Safety and Compliance for Kraft Heinz North America. He has more than 30 years of international experience in food safety, quality management, and risk mitigation. Prior to joining Kraft Heinz, Campbell served as Vice President of Quality and Safety at Fairlife LLC, a $4-billion Coca-Cola-owned dairy brand. He has also held senior leadership roles with Kerry Group and Almarai in the Middle East. Additionally, he founded a consultancy that supported Tiger Brands in Africa.