Food Safety Modernization Act (FSMA)

The recent rule changes associated with the Food Safety Modernization Act (FSMA) will have a dramatic impact on the food safety and regulatory landscape for facilities producing products regulated by the FDA, and compliance deadlines for FSMA are quickly approaching. Although dietary supplements are exempt from the preventive controls requirements of 21 CFR 117, the preventive controls are just one part of the seven new rules implemented by FSMA.

Dietary supplements are still subject to other parts of 21 CFR 117 and are required to be compliant with the other applicable rules and regulations established under FSMA.

This FSMA training course will provide an introduction to all seven new rules and regulations established by FSMA and provide insight on which rules impact dietary supplement companies. The course will also provide tools, references and ideas for implementing the changes needed to comply with FSMA regulations.

At the end of the course, you will know and understand:

• What FSMA is and where to find the new regulations
• Who and what the FSMA requirements impact
• Dietary ingredient suppliers
• Dietary supplement manufacturers
• Food manufacturers
• Understand the difference between HACCP and HARPC
• Understand what is required for:
  • Food safety plan
  • Hazard assessment
  • Risk-based preventive controls
  • Verification activities
  • Supply chain program
  • Foreign Supplier Verification Program
  • Food defense plan and adulteration
  • Sanitary transport requirements
• Provide tools, references and ideas for implementing FSMA

• Management
• Marketing
• Quality control/assurance
• Packaging
• Laboratory operations
• Product development
• Suppliers and distributors
• Regulatory affairs
• Legal

Course instructors will be selected from the following:

Jennifer Alfrey - Jennifer has a master’s degree in nutrition and over 25 years of experience in the dietary supplement and cosmetic industries. Her experience ranges from product innovation to global regulatory compliance with experience in formulating, developing, and registering nutrition and cosmetic products in over 150 different countries.

Jennifer has also successfully built cGMP compliant quality management systems from the ground up for dietary supplement manufacturing operations. She has launched quality systems that include compliant documentation of procedures, MMRs, specifications, complaints, laboratory testing, test method development and manufacturing processes.

Norman Howe - Norman Howe is an experienced quality consultant. Norman has taught a course in quality systems as adjunct faculty at the University of Michigan, Ann Arbor. He serves as an expert witness in FDA-regulated product quality cases.

Previously, Norman was the plant manager of a pharmaceutical plant with BASF and was responsible for manufacturing, quality assurance, engineering, maintenance, contract manufacturing and a small product development group.