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)

Adam Holt, BCE is a Board Certified Entomologist with decades of hands-on experience. He is the Founder and Principal Consultant at NameDatBug, a pest control consulting firm grounded in real-world success across every level of the pest control industry. Adam has held executive roles at several PCT Top 100 companies and brings unmatched industry expertise to every engagement. He holds a patent for an electronic rodent monitoring device, has worked in pest control software development, and has collaborated closely with manufacturers and distributors on both product design and market strategy.

Shannon Sked, Ph.D., BCE is an entomologist and the National Technical Director at Orkin. He received a B.S. degree from Rutgers University, an M.S. degree in Entomology from Penn State University, and a Ph.D. from Rutgers' Urban IPM Entomology lab. Dr. Sked's research focuses on distribution and temporal modeling of insect and rodent communities in order to design effective pest management programs. He began his career as a Navy Entomologist overseeing structural pests, specifically focusing on pests related to imports, exports, and within the logistics chain for Navy operations. He had the unique opportunity to practice applied entomology and invasive species management in the Middle East, North Africa, the Caribbean, and the eastern shore of the U.S.  

Michael Ciepiela is Vice President of Quality and Continuous Improvement at Southern Specialties. He brings over a decade of diverse experience in the food and beverage industry, along with experience in the pharmaceutical sector, specializing in quality assurance and food safety. Throughout his career, he has excelled in multi-site implementation and adherence to GFSI requirements and regulations. Michael has also been instrumental in promoting and educating Lean Six Sigma principles in fast-paced, cross-departmental settings. As a recognized thought leader, he frequently speaks at national conferences. He is also a senior member of the American Society for Quality (ASQ). Michael holds a bachelor's degree in Biology from Alfred University and a Six Sigma Master Black Belt from Villanova University.

Mindy Brashears, Ph.D. is the U.S. Department of Agriculture's (USDA's) Under Secretary for Food Safety. She previously served as Under Secretary for Food Safety from 2020–2021, and Deputy Under Secretary in 2019. Dr. Brashears returns to USDA from Texas Tech University, where she was a Paul Whitfield Horn Distinguished Professor of Food Safety and Public Health, the Roth and Letch Family Endowed Chair for Food Safety, and the Director of the International Center for Food Industry Excellence.

Carmen Rottenberg is a leader in food safety and agriculture policy, serving as Managing Director of Groundswell Strategy a Board Member for the Partnership for Food Safety Education. Prior to launching Groundswell Strategy, Carmen served as Administrator of USDA's Food Safety and Inspection Service. Over her 13 years with USDA, Carmen held several leadership roles and was credited with spearheading key agency initiatives including modernizing food safety inspection systems and establishing and updating pathogen performance standards. Carmen has extensive experience achieving collaboration across federal, state, and municipal agencies including with the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), with state departments of agriculture and across USDA's 29 agencies and offices.

Jules Shepard is the CEO and Founder of gfJules, the number-one‑voted gluten‑free flour and baking mixes company in the United States. A recognized gluten‑free baking expert, she has authored three award‑winning books in the field and recently released a new cookbook dedicated to gluten‑free bread. A long‑standing and respected leader in the gluten‑free and food allergy community, Jules championed the gluten‑free food labeling movement in 2011. Her tireless advocacy, education, and lobbying efforts culminated in her receiving the first‑ever "Gluten Free Person of the Decade" award in 2020.

Lily Yasuda is the Deputy Director of the Alliance to Stop Foodborne Illness, where she leads national initiatives that bring together food industry leaders to strengthen food safety culture and support continuous learning across the sector.

Athenais Boeffard is a collaborative and people-focused production leader with over a decade of experience in food manufacturing and food safety. 

John Boyce has over 45 years of experience in various aspects of food production, food safety, quality assurance, sanitation, training, and auditing.