When your FDA inspection ends with delivery of a "Form 483 — Inspectional Observations," you have only 15 business days to convince the agency you understand its concerns and put a corrective plan in place. If the FDA doesn’t receive a response letter in that timeframe, it will proceed to consider enforcement action without your input.

In this FDAnews webinar, former FDA investigator Sarah Tanksley provides an extensive outline on how to prepare well-crafted 483 responses. Her insights will benefit any company that is inspected by the FDA, including manufacturers of medical devices, pharmaceuticals and biologics.

Webinar Takeaways:

  • Real-life examples of how to — and how not to — respond to 483 observations.
  • A practical framework for planning a timely response to inspection findings.
  • The means to identify typical response failures and plan corrective actions.
  • A method for responding to problematic inspections, such as more serious observations, repeat observations, or when you disagree with the findings.
  • How to quickly create a plan that includes immediate action, as well as how to make clear commitments to address issues that can't reasonably be implemented right away.

When crafting your 483 response in a tight timeframe, it must be well-planned, thorough, and convincing. Attend this webinar and gain expert insights into what the FDA expects to see in a 483 response. Secure your spot today.

Who Will Benefit:

  • Regulatory affairs professionals
  • Compliance staff
  • Quality staff
  • Consultants