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  • Responding to Device Warning Letters: What You Must Do To
    Avoid Further Enforcement Action

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - Jun 07, 2013 10:00 AM
  • End Time:
  • Friday - Jun 07, 2013 11:00 AM
  • Location:
  • Online
  • This webinar on FDA warning letters will discuss proven strategies for how to respond to warning letters correctly and 'adequately' the first time. The examples and case studies shared in this webinar are specifically designed to benefit medical device companies.

    Why Should You Attend:

    Just one quick glance at some of the Warning Letters issued by the FDA and you will see an all too common response to companies that have attempted to answer a Warning Letter. The FDA's response frequently read like this: "We reviewed your firm's response and concluded that it is not adequate."
    Don't let this happen to you! Attend this webinar to learn proven strategies for how to respond to warning letters correctly the first time. We will cover the absolute essential requirements for responding to FDA warning letters. Additionally, you will learn specific actions to take within your organization that will not only clear the warning letter quickly but improve your business performance.

    Any medical device company can find themselves staring at a warning letter from the FDA. With the required 15 day response deadline, knowing how to respond appropriately is an essential skill to have. Don't wait until you receive a warning letter to learn how to respond correctly the first time.

    Areas Covered in the Webinar:

    - Brief review of types of enforcement actions from the FDA
    - What is a Warning Letter and what does it mean?
    - Do's and Don'ts of responding to Warning Letters
    - Actions to take to support the response
    - Communicating with the FDA after the Warning Letter
    - Real examples of good and bad responses
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