Home » Multimedia » Podcasts » Food Safety Matters » Ep. 24. Melanie Neumann: Getting Ready for Your FSMA Inspection
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.
Melanie Neumann is the president of Neumann Risk Services, and executive vice president of Matrix Sciences—a firm that focuses on food safety risk management, business and brand protection, regulatory compliance, and industry best practices. Melanie leverages her 19 years of industry experience as a food law attorney along with her Masters of Science in Food Safety to help clients manage the risks relating to each step in the supply chain, from supplier assessment and procurement, manufacturing, distribution and sale of food globally.
She is a graduate of Mitchell-Hamline Law School for her Juris Doctorate degree, and Michigan State University for her M.S. in Food Safety. She has worked for multi-national food companies such as Hormel Foods, The Schwan Food Company, private law firms focusing on food law and intellectual property law, was instrumental in launching national food safety risk management practices for one of the “Big 4” tax and auditing firms as well as for other well-known consulting firms.
She is an Adjunct Professor at Michigan State University and serves on advisory panels and boards of several notable organizations. Melanie is a frequent speaker on executive liability in food production and food regulations including FSMA regulations. Outside of her profession, Melanie is an avid triathlete, to date completing 25 marathons and six Ironman triathlons.
In this episode of Food Safety Matters, we speak to Melanie Neumann about:
The level of difficulty involved when it comes to food companies having to implement FSMA
The difference between understanding a regulation vs. implementing it vs. operationalizing it
How much legal interpretation is really required to understand how to properly implement FSMA
Melanie’s view of how FDA regulators and food companies are working together during inspections in the beginning stages of FSMA
The importance of explaining the "why" behind FSMA regulations, why they exist, and why behaviors in the food facility need to change
FSMA's effect on global food companies
How FSMA stacks up against ISO, GFSI and international standards in general
What happens during an FDA inspection if a QA manager or food safety staff member cannot answer questions accurately or knowledgeably
The number one factor that causes a food plant to be non-compliant with some part of a FSMA rule or regulation
How poor records management can make or break a food company, and the benefits of electronic record-keeping
What's involved in a readiness assessment?
Crisis management planning and after-action assessments
Melanie's thoughts on mock recalls and crisis simulations
Why food companies can no longer afford to ignore social media and what people are saying about their products
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.