Regulatory Complaint Handling, Vigilance & Recalls

Product Id: 600082

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)

    Original Price: $295
    Special Offer Price: $10
  • Refund Policy


Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line.

Recalls, FDA Warning letters & even seizures could result.

This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.

Areas Covered in the Session:

  • Complaints Definitions; FDA, EU & Canada
  • How to Document Complaints & Adverse Events
  • US & Foreign Regulatory Reporting
  • Recall, Vigilance, Correction & Removals
  • Enforcement Actions

Who Will Benefit:

  • Regulatory Professionals
  • Quality Engineers
  • Manufacturing Engineers
  • Operations Executives
Speaker Profile
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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