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Working With FDA: Practical Insights from a Former FDA Official

March 27 @ 12:00 pm - 1:00 pm EDT
Safetychain - Logo

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About This Session

Navigating interactions with the FDA can feel complex, high-stakes, and often uncertain for food and beverage manufacturers. In this FSMA Friday session, Don Kautter of The Acheson Group (TAG), a former FDA official with deep experience in inspections, compliance, and regulatory policy, offers clear, practical guidance to help companies engage confidently and effectively with the Agency.

What You Will Learn

  • What FDA investigators prioritize during facility inspections, and how they evaluate your documentation.
  • How to prepare teams, records, and environmental monitoring data to avoid common FDA inspection findings.
  • Behaviors, communication practices, and on-site actions that build trust and credibility with FDA personnel.
  • How to respond effectively to FDA inquiries, 483 observations, and follow-up requests.

Details

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