Recalls & Vigilance-When to Report Complaints

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

Overview:

This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints.

FDA has issued warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA’s website and published in trade magazines, newspapers available to firms' competitors.

Areas Covered in the Session:

  • Complaint definitions-FDA, Canada & Europe
  • FDA’s complaint handling requirements
  • Canada & European Union complaint handling
  • FDA’s voluntary & mandatory reporting
  • 21CFR 803, 806 & 810 explained
  • FDA regulatory actions against firms
  • Adverse event reporting – Canada & Europe

Who Will Benefit:

  • Design Engineers
  • Regulatory Professionals
  • Technical Writers
  • R & D Managers
  • Design Engineers
  • QA Managers
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.


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