Covington’s Medical Device Webinar Series: How to Effectively Respond to FDA 483s and Warning Letters

November 1, 2017

Receiving an FDA 483 or Warning Letter following an inspection can be a traumatic — and costly — event for a device company. But an effective response can mean the difference between a 483 escalating to a Warning Letter, or a Warning Letter escalating further. This webinar will:

  • Provide an overview of Form FDA 483s and Warning Letters, including the primary areas of FDA enforcement scrutiny
  • Discuss key strategies for preparing an effective response
  • Describe pitfalls that device manufacturers often encounter in response preparation

The webinar will be led by Pamela Forrest, Scott Danzis, and Doug Poucher, each of whom has extensive experience advising companies on postmarket and enforcement matters.

  • Pamela Forrest is a Partner in Covington’s Food, Drug, and Device practice and has over 20 years of experience in advising clients on a wide range of FDA medical device regulatory issues, including postmarket enforcement matters such as compliance with FDA’s QSR and MDR reporting obligations.
  • Scott Danzis is a Partner in Covington’s Food, Drug, and Device practice whose practice focuses on FDA regulatory issues for medical device companies; Scott formerly  worked in FDA’s Office of Chief Counsel, where he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs.
  • Doug Poucher is a Senior Advisor in Covington’s Food, Drug, and Device practice and has over 39 years of experience in FDA matters, including over 16 years as an FDA investigator; Doug has deep expertise in the QSR regulations for medical devices and CGMP regulations for pharmaceutical products.

Registration

If you like to register,  please contact Jordyn Pedersen at jpedersen@cov.com.

Upcoming Webinars

  • Covington’s Digital Health Webinar Series: The Evolving FDA and EU Equivalent Regulation of Digital Health
    November 14, 2017
  • Covington’s Medical Device Webinar Series: Developments in Medical Device Regulation in China
    Presented by John Balzano
    December 6, 2017

If you have any questions or would like to receive information about these webinars, please contact Jordyn Pedersen at jpedersen@cov.com.