FSMA and Beyond: Documentation and Records Management as a Food Manufacturing Best Practice

  • FDA expectations for FSMA documentation compliance
  • Best practices in developing Food Safety Plans and Food Defense Plans
  • Organizing and documenting your Supply Chain Program
  • FDA records access
  • Litigation implications of documentation and documentation practices

Stuart Pape
Chair Food & Drug
Polsinelli PC

Stuart assists clients in understanding and complying with regulations imposed by the FDA, USDA and similar health and safety regulatory bodies worldwide. He serves as the chair of Polsinelli’s Food & Drug Group. Stuart regularly appears before the FDA, USDA, the Consumer Product Safety Commission, the U.S. Customs and Border Protection, Federal Trade Commission, numerous other federal and state regulatory bodies, and the Congress of the United States. Previously, Stuart served in various positions in the Office of the Chief of Counsel at the FDA, including as Associate Chief Counsel for food. He also served as Executive Assistant to FDA Commissioner Donald Kennedy.

Dennis Dobbels
Co-Chair Food & Ag
Polsinelli PC

Dennis Dobbels offers clients an extensive background in all aspects of products liability, toxic tort and legacy liability, tax litigation, and insurance and complex commercial litigation. Dennis serves as Chair of the firm’s national Products Liability and Toxic Tort practice, as well as Co-Chairing the Food & Agricultural Group. In state and federal courtrooms around the nation, Dennis has handled single plaintiff cases and consolidated cases involving more than 100 plaintiffs. He also serves as National Trial Counsel, assisting clients with complex litigation issues.

Kathy Hardee
Co-Chair Food & Ag
Polsinelli PC

Kathy serves as Co-Chair of Polsinelli’s Food & Agriculture Group. Ever monitoring, writing and speaking on changes in food laws, Kathy serves as a Risk Manager for clients in an attempt to reduce litigation exposure. Should the need arise, she has extensive nationwide trial experience. Kathy is certified as a Preventative Controls Qualified Individual (PCQI) under FSMA and is HACCP qualified. She is also a trained mediator. Kathy represents clients in the food industry, toxic and mass tort litigation, product liability issues, business disputes and transportation disputes.