President, Chief Technical Director
Lead Instructor, FSPCA FSMA Foreign Supplier Verification Programs
Lead Instructor, FSPCA FSMA Preventive Controls for Human Food
Lead Instructor, International HACCP Alliance
Nancy Scharlach is the President and Chief Technical Director for Soterian Systems, LLC and FSMA International. She is a Lead Instructor for FSPCA FSMA Preventive Controls for Human food (certificate #7323330), FSPCA Foreign Supplier Verification Programs (certificate #7e62ff08), and a Lead Trainer through the International HACCP Alliance. Nancy is a food safety and quality professional and has been a Registered SQF Consultant in High Risk Processing since 2010 (SQF Registration No: 9717 – FSC #’s: 3, 4, 10, 13, 14, 15, 16, 18, 19, 20, 21, 22, 23, 24, 25, 26, and 35).
Nancy earned a B.S. in Microbiology from the University of Montana in 1996, and has worked in the food industry her entire career. With 23 years of global food safety experience, Nancy has worked for nationally recognized companies such as The Schwan Food Company, The Hain Celestial Group, and Jamba Juice Company. In 2008, Nancy founded Soterian Systems, LLC, a consulting, coaching and training food safety and quality firm that services the global market. In response to helping US Food Importers comply with new FSVP regulations, Nancy developed a process to represent importers and comply with the FSVP rule in early 2017. The services are now expanding into international FSMA services such as online and classroom training in various languages, program development tools and food safety regulatory compliance coaching under FSMA International.
Nancy has extensive experience working with domestic and international processors and growers in countries such as India, Thailand, Vietnam, Mexico, China, Chile, Argentina, Brazil, Peru, Ecuador, Guatemala, Costa Rica, and Canada. Her experience expands to working globally in over 2000 manufacturing facilities and hundreds of produce growers. Nancy’s worldwide travel and global boots on the ground experience with food manufacturers and growers has allowed her to service clients’ needs in various cultural food safety compliance challenges.
Nancy’s diverse knowledge and expertise in the food industry includes high risk processing in USDA and FDA RTE fresh and frozen meal and products, High Pressure Processing (HPP), fresh cut produce, Good Agricultural Practices (GAPs), and fresh produce harvesting, fresh and frozen dairy manufacturing, retail QSR, IQF fruit and vegetables, bakery and snack products, sprouted seed products, food contact packaging, thermally processed and commercially sterile products, single strength juices, thermally processed sauces, salsas and canned goods, pasta items, and distribution and warehouse storage practices, pet food products, dietary supplements and nutraceuticals.
Nancy has authored extensive HACCP & FSMA Food Safety Plans, FSVP Plans for Importers and Quality and Food Safety Management Systems for numerous companies worldwide in addition to working with processors at the facility level to integrate the best practices in the industry and to comply with regulatory and customer requirements. Nancy also works with clients to conduct microbiological challenge studies on product and equipment to achieve validation programs for food safety. Most recently, Nancy has worked onsite with global food companies on creating, implementing, and training all levels of employees and management on the new FSMA Food Safety Plans and cGMPs.