John Chapman
Instructor John Chapman
Product Id 600082
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Regulatory Complaint Handling, Vigilance & Recalls


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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