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)

Lucy Angarita is the Director of Food Supply Chain visibility at GS1 US, where she works with retail, grocery, foodservice, and healthcare companies to increase data quality, operational efficiencies, and full supply chain traceability. With over 20 years of experience in program management and process improvement, as well as a Six Sigma Black Belt certification, she has a passion for solving complex problems and delivering value to customers and stakeholders.

Haley F. Oliver, Ph.D. is the Director of the Feed the Future Food Safety Innovation Lab at Purdue University. She is also the Vice Provost for Graduate Students and Postdoctoral Scholars and the 150^th Anniversary Professor of Food Science at Purdue University, renowned for her expertise in food safety microbiology. She earned dual B.S. degrees in Molecular Biology and Microbiology from the University of Wyoming in 2004, followed by a Ph.D. in Food Science, with minors in Epidemiology and Microbiology, from Cornell University in 2009. After completing a postdoctoral fellowship at Cornell, Dr. Oliver joined Purdue University in 2010. 

Justyce Jedlicka serves as the Food and Beverage Regulatory Liaison in North America for MilliporeSigma, where she is responsible for engaging with influencers in the food and beverage industry to align initiatives with regulatory compliance and promote best practices for food safety and quality testing methods. Justyce has been serving the food and beverage industry since 2013, and received both a B.S. degree in Chemistry and an M.B.A. degree from the University of Missouri in St. Louis. She currently serves as the Food Sciences Section Chair and Executive Board Member of the American Council of Independent Labs, and is a member of the International Association for Food Protection (IAFP), the International Society of Beverage Technologists (ISBT), and AOAC International.

Sally Powell Price is MilliporeSigma's Regulatory and Public Health Expert for Food and Beverage Safety Testing in North America. Previously, she served as Director of Lab Operations at a biotech startup in Boston and was the Food Lab Supervisor at the New York City Department of Health Public Health Laboratory. She holds a B.S. degree in Biology from Hamilton College, an M.S. degree in Microbiology and Immunology from James Cook University in Australia, and did continuing coursework in public health and foodborne disease at Harvard TH Chan School of Public Health. She is a member of the Association of Food and Drug Officials (AFDO), the Association of Public Health Laboratories (APHL), the International Association for Food Protection (IAFP), and AOAC International.

Thomas Gremillion, J.D., M.A. is the Director of Food Policy at the Consumer Federation of America (CFA). He oversees research, analysis, advocacy, and media outreach for the group's food policy activities, and monitors food safety activities at the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and in Congress, where he advocates for strong food safety protections for consumers. He also coordinates the Safe Food Coalition, a group of consumer, trade union, and foodborne illness victim organizations dedicated to reducing foodborne illness by improving government food inspection programs.

Paul Shapiro is the author of the bestselling book, Clean Meat: How Growing Meat Without Animals Will Revolutionize Dinner and the World. He is also CEO of The Better Meat Co., a company that uses fermentation to turn microbes into alternative meat. Paul is a five-time TEDx speaker, the host of the Business for Good Podcast, and a long-time leader in food sustainability.

As an authority on food and agriculture sustainability, Paul has been interviewed by numeorous news outlets—ranging from CNN to StarTalk Radio with Neil deGrasse Tyson. He has also published hundreds of articles in publications like the Washington Post, Scientific American, FORTUNE, and academic journals. In 2023, Paul was named as a Most Admired CEO by the Sacramento Business Journal.

Johanna Velez is Vice President of Quality Assurance for Monin Americas, having joined the brand in 2002. With more than 27 years in the food industry, Johanna has a wealth of experience in leading, directing, and guiding the company’s food safety and quality programs at all Monin North America locations. She successfully led Monin to achieve Safe Quality Foods (SQF) and Organic certifications for both the Clearwater, Florida and Sparks, Nevada facilities, resulting in an "Excellent" rating for the brand’s food safety practices. Prior to Monin, Johanna spent five years at Wild Flavors (now Archer-Daniels-Midland Company) in Cincinnati, Ohio. She is a member of the Institute of Food Technologists (IFT), including the Florida IFT Division, as well as the Bay Area Manufacturers Association (BAMA). Johanna graduated from Louisiana State University and later attended Michigan State University to obtain her certification in Food Law and Regulations.