Home » Multimedia » Podcasts » Food Safety Matters » Ep. 20. Larry Keener: Validation Before Verification
Food Safety Matters
Food Safety Matters is a podcast for food safety professionals hosted by the Food Safety Magazine editorial team – the leading media brand in food safety for over 20 years. Each episode will feature a conversation with a food safety professional sharing their experiences and insights of the important job of safeguarding the world’s food supply.
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
James (Jim) Jones joined the U.S. Food and Drug Administration (FDA) in September 2023 as the agency's first Deputy Commissioner for Human Foods. In this position, he leads the charge in setting and advancing priorities for a proposed, unified Human Foods Program, which includes food safety, chemical safety, and nutrition activities. He currently oversees the leadership of the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR), until the proposed Human Foods Program reorganization is implemented.
Robert (Bob) Manning, M.B.A., M.S., M.E.M., has worked in the food and beverage industry for over 25 years in various facility and senior corporate positions. He is currently CEO of Liquid, and formerly worked as Vice President of Technical Operations at Niagara Bottling. He has spent most of his time in Operations and Quality roles for large companies such as HP Hood LLC, Campbell's Soup, and Niagara Bottling, as well as consulting for major domestic and international firms.
Brittany Sambol is the Vice President of Operations at Wildtype Foods, where she is responsible for leading the scale-up of the company’s operations function, including product commercialization and manufacturing facility expansion. Prior to joining Wildtype, Brittany spent six years at Clif Bar & Company, leading in various areas including supply chain and contract manufacturing management, product innovation and scale-up, and sustainable packaging development. Earlier in her career, Brittany worked as a chemical engineer and then spent over 12 years directly leading manufacturing operations in the CPG industry.
Khyati Shah, Ph.D. is an esteemed molecular biologist with a distinguished career spanning over ten years in the development and promotion of innovative pathogen testing of products for the food and beverage industry. Serving as a global product manager for the Food and Beverage segment of the Life Sciences business of MilliporeSigma, Dr. Shah is instrumental in creating and spearheading the product roadmap for the cultured meat and alternative protein business. With MilliporeSigma's strong focus on providing research and development (R&D) to scale-up solutions in this emerging industry, Dr. Shah enables cost-effective, sustainable, and efficient supply chain solutions to bring cultured meat and seafood products to market.
Jason Richardson, Ph.D. is the Vice President of Global Quality and Food Safety of The Coca-Cola Company, a position he has held since January 2021. In this role, Jason leads a team of quality and food safety professionals who are accountable for delivering global strategic and operational leadership for the performance and progress of quality and food safety programs across the Coca-Cola system.
Brian Ronholm, M.A.,is the Director of Food Policy for Consumer Reports, where he leads advocacy efforts to advance a safe and healthy food system. He was in public service prior to joining Consumer Reports, having served as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA), and before that, as a congressional staff person for Congresswoman Rosa DeLauro of Connecticut.
Natalie Dyenson, M.P.H. is the Chief Food Safety and Regulatory Officer for the International Fresh Produce Association (IFPA). She has nearly three decades of experience in food safety that encompasses the entire produce supply chain, from farm to fork. In her role at IFPA, Natalie and her team actively work to guide the industry on food safety issues and connect with regulators and policymakers to advocate for a science-focused and risk-based approach to food safety worldwide.