Responding Effectively to FDA 483 Observations and Warning Letters

45 Minute Video | Pamela Forrest, King & Spalding

Many organizations and executives will at some point be faced with addressing an FDA-483 or Warning Letter.  The process of responding is a stressful time within a medical device organization, and 483s and Warning Letters are becoming increasingly rigorous and complex.  Indeed, failing to respond effectively can have serious consequences for device manufacturers.  This session will:

  • Step attendees through the process of preparing an effective response to Form FDA-483s and Warning Letters
  • Identify strategies for avoiding common pitfalls that firms encounter when preparing a response
  • Discuss the potential implications of failing to submit an effective response

 

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Quality Management
  • Quality Systems
  • Regulatory Affairs

 

forrest-pamela
Pamela Forrest
Partner
King and Spalding

Pamela Furman Forrest is a partner in King and Spalding’s FDA and Life Sciences Practice Group. Ms. Forrest joined the firm in 2007, and has nearly 20 years of experience in advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, reclassification, import/export issues, Investigational Device Exemption (IDE) requirements, and combination product issues. In addition, Ms. Forrest frequently assists medical device manufacturers, investment banks, and private equity funds with due diligence evaluations of FDA-regulated companies.


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