FDA MDR Enforcement Actions: Best Practices for Strengthening MedWatch Form Writing and Reporting

A common enforcement action sited in FDA warning letters in recent years pertains to the failure to properly and fully complete a MedWatch Form (FDA 3500A). Complaint reporting teams are tasked with compiling these complex reports and ensuring that the information entered is consistent with underlying complaint files and internal documents. In order to ensure compliance with the FDA, device manufacturers must ensure that MedWatch forms are factual and fully per FDA requirements.

  • In-depth review of MedWatch report requirements and writing techniques
    • Determining what details to include
    • Mitigating the use of speculative language
    • Recognizing overall writing tone
  • Comparison of complaint files vs. MedWatch reports to ensure consistency
  • Addressing common MedWatch pitfalls and strategies to overcome

 

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:

  • Complaint Management
  • Device Reporting
  • Regulatory Affairs
  • Postmarket Surveillance

 

 

 

 

Adriana M. Russell
Quality Assurance
Formerly of Zimmer Biomet

Adriana M. Russell (name in bold??) is a Quality Assurance professional with over 14 years of experience in the pharmaceutical and medical device industry and previously held positions at Zimmer Biomet, LDR Spine, and Worldwide Clinical Trials. Her most recent areas of expertise include post market surveillance as she managed the company’s event reporting (Complaint Handling) system and was responsible for timely decision making regarding Medical Device Reports (MDRs), generating MDRs, and ensuring timely reporting.


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