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)

Edward G. Dudley, Ph.D. is the Director of the E. coli Reference Center and a Professor of Food Science at the Pennsylvania State University. He has a broad background in molecular biology, physiology, and foodborne bacteria genomics, with expertise in both beneficial and pathogenic species. His current research program focuses on factors that drive the virulence of Escherichia coli O157:H7 and the development of DNA sequence-based methods for tracking pathogen spread during foodborne illness outbreaks, including wastewater monitoring. 

Phil Kafarakis is the President and CEO of IFMA The Food Away from Home Association, formerly known as the International Foodservice Manufacturers Association. He is responsible for overseeing IFMA's day-to-day operations and directing the activities of the association in support of its policies, goals, and objectives. Phil is a highly accomplished senior executive with broad experience leading major food industry companies and associations. He began his industry career in the manufacturing sector, successfully leading and managing businesses at Kraft, Jones Dairy Farm, Cargill, and McCormick & Co., where he also served on IFMA's Board of Directors. He also previously served as President of the Specialty Food Association (SFA) and as the Chief Innovation and Member Advancement Officer at the National Restaurant Association (NRA).

Mark Carter is the Senior Software Product Manager at Hygiena. He assumed the presidency of the International Association for Food Protection (IAFP) at the conclusion of the IAFP Annual Meeting in July 2024.

Mr. Carter has extensive international business and technical experience. He most recently served as COO of Matrix Sciences, as well as the Executive Vice President of Corporate Development, where he was responsible for Matrix Sciences Mergers and Acquisitions activity. He previously held positions as CEO of QC Laboratories and Corporate Vice President of Research and Development with the Silliker Group Corporation (now Mérieux NutriSciences). He has served within the food industry as Section Manager for Microbiology and Food Safety at Kraft Foods and Corporate Laboratory Group Leader at McKee Foods Corporation.

Jason Evans, Ph.D. is the Dean of the College of Food Innovation and Technology (CFIT) at Johnson & Wales University, which offers baccalaureate and graduate programming in Culinary Arts, Culinary Science, Culinary Nutrition, Food and Beverage Entrepreneurship, and Sustainable Food Systems.

Kimberly Baker, Ph.D. serves as the Food Systems and Safety Program Team Director and an Associate Extension Specialist with the Clemson University Cooperative Extension Service. She received her Ph.D. in Food Technology from Clemson University and is both a registered and licensed dietitian, as well as a trained chef.

Natalie Rainer, J.D., M.P.H. is a Partner and a Member of K&L Gates LLP's Health Care and FDA practice. She focuses her practice primarily in the food and beverage industry. Natalie practices food and drug law, advising clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world, including North America, Latin America, Europe, Asia, and the Middle East.

Peter Coneski, Ph.D. is a Senior Scientific Advisor in K&L Gates LLP's Health Care and FDA practice. He provides technical assistance in evaluating the regulatory compliance of food additives and food contact materials in the U.S. and other jurisdictions. He also develops strategic testing plans and protocols for analytical data acquisition that support industry filings to regulatory agencies globally. In addition to his work related to food additives and food packaging materials, Peter advises clients on global sustainability initiatives, Extended Producer Responsibility schemes, and compliance with emerging legislations impacting companies operating in a global marketplace.