To continue providing education for real world situations (“where the rubber hits the road…”) we present our ongoing Education Series. Learn from experts how to succeed with your business.
Topic: Food Safety Modernization Act and Foreign Supplier Verification
When: September 20, 6:00 – 8:00 PM
Where: Impact Hub Boulder (1877 Broadway, Boulder)
The FDA Food Safety Modernization Act (FSMA) was signed into law in 2011. After years of rule making, the compliance dates for small and very small businesses have hit in 2017 and 2018 respectively. If you have a food company, you need to know how this law impacts you. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also gives FDA new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards. This session will provide a high level overview of the key components of this new law and share insights on where Naturally Boulder members can turn for additional help.
Learn from the Experts
Nancy Scharlach, Chief Technical Director , FSMA International
Scott Sellers, Enterprise Sales Executive, TraceGains
Jeni Lamb Rogers, Attorney, Faegre Baker Daniels
Kyle Garner, CEO, Organic India USA (Event Organizer)
Members: $25, Non-members $35 (Includes catering)
Jeni Lamb Rogers, Attorney Faegre Baker Daniels LLP
Jeni is part of the nationally ranked food litigation and regulatory practice at Faegre. Additionally, she is a part of national recall and trial teams for national foodborne illness outbreak related litigation. Jeni’s regulatory experience includes the following:
Advising startup food businesses on compliance with FDA Food Safety Modernization Act (FSMA) requirements and the Foreign Supplier Verification Program
Advising on compliance programs for the Dietary Supplements CGMP, serious adverse event reporting
Assisting FDA regulated food facilities to prepare for domestic and foreign inspection
Negotiating processing, supply and contract manufacturing agreements for food brands and manufacturers
Reviewing product labeling and packaging to comply with FDA, FTC and USDA regulations to reduce risk of regulatory enforcement and consumer claims
Jeni specializes in advising start-up clients in the natural and organic product space, devoting more than half of her practice to working with emerging and leading natural and organic food and dietary supplement brands.
Before joining Faegre Baker Daniels, Jeni was an associate at Holland & Hart LLP. She also started a non-profit soy processing business for farmers living with HIV in western Kenya; has worked on conservation agriculture research projects in Kenya, Uganda and Lesotho; and worked for a food hub aggregating conventional and organic produce and consumer packaged goods. While working in agricultural policy, Jeni worked on food safety, germplasm conservation, and trade issues with the American Seed Trade Association, Senate Committee on Agriculture Nutrition and Forestry, and the House Committee on Agriculture.
Jeni is a Food Safety and Preventive Controls Alliance Preventive Controls Qualified Individual (PCQI) for Human Food and is a Produce Safety Alliance Trainer of Trainers for the Produce Safety Regulation.
Scott has decades of experience in sales for food and ingredient manufacturers. Later he branched out into big data and software to bring technology solutions to the food, beverage, and supplements industries. He talks daily with leaders in the top 100 companies in food and beverage and has keen insights into the regulatory and business challenges they face.
TraceGains is a rapidly growing software company, delivering a sophisticated suite of products for food, beverage, and CPG companies. TraceGains solutions empower customers to satisfy compliance with regulations and industry standards such as FSMA, GFSI, and HACCP/HARPC, without the need for additional staff.
At the heart of TraceGains is a robust platform that enables companies to automate and optimize their processes through instant information sharing and collaboration between supply chain partners, which saves time and improves food safety and quality.
Nancy 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 over 20 years of 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 founded FSVP Partners, Inc. in early 2017 and is now expanding and developing international FSMA services such as online and classroom training in various languages, program development tools and 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.
Board Member focusing on monthly events and special opportunities. Kyle Garner, is the CEO of ORGANIC INDIA USA, a leading mission-driven manufacturer of herb-based wellness teas and functional supplements based on the principles of Ayurvedic medicine. Kyle joined ORGANIC INDIA USA in April 2015 following 3 years as CEO of New Chapter, Inc. in Brattleboro, VT. Kyle joined New Chapter in June 2012 following the acquisition by Procter & Gamble. Under his leadership, the New Chapter brand scaled-up in all facets including sales, marketing, scientific research, certifications, and innovation. He led the process for New Chapter to achieve B Corp certification. Kyle began his career with P&G working in Consumer and Market Insights for the Fabric Care business in 1998. He served in a variety of roles on both the consumer and retail sides of the P&G business. He moved into P&G Health Care in 2009 where he played a leadership role in the development of a Joint Venture with Teva Pharmaceuticals and the acquisition of the New Chapter business. Kyle earned a Bachelor’s Degree from Miami University in Oxford, Ohio. Kyle lives in Boulder with his wife (Maggie), 6-year-old son (Oscar), 2-year-old daughter (Audrey), and giant, fluffy dog (Belle). In his spare time, he enjoys gardening, beer, and making pickles.