As of July 1st, 2016, 360 Performance Circle has become
Kaizen Online, a part of Kaizen Institute


FDA Compliance

Quality Systems Training
How to prepare for an FDA quality systems inspection
Disk 08
Complaint Handling and Servicing
Video Length:
ID# DTA108

Disk 8 of 10  (37 minutes)

You can buy the individual disks, or you can buy the complete training set for a 30% savings. 

CD of one of ten training sessions


  • Introduction
  • Complaint handling 21 CFR § 820.198
  • Definition:  complaint
  • Situation analysis - complaints
  • Situation analysis - user error
  • Complaint files & procedures
  • The preamble on documenting oral complaints
  • MDR reportable complaints
  • Adverse event vs. MDR reportable event
  • MDR and surgical intervention
  • Complaints not investigated
  • Preamble on initial complaint review
  • Complaint investigations
  • The preamble on duplicate investigations
  • MDR reportable complaints
  • MDR reportability of adverse events occurring outside of the U.S.
  • Q:  Which of the following “complaints” would not require an investigation?
  • Documenting complaint investigations
  • Complaint investigations
  • The preamble on complaint investigations
  • Situation analysis - complaints and design changes
  • Additional information for MDRs
  • Complaint record accessibility
  • The preamble on complaints not maintained at manufacturing site
  • Foreign complaint records
  • Servicing requirements 21 CFR § 820.200
  • The preamble on servicing
  • Servicing instructions
  • The preamble on servicing to “meet specified requirements”
  • Analysis of service reports
  • The preamble on corrective action for service requirements
  • Reporting service reports under MDR
  • Situation analysis
  • Documenting service reports
  • The preamble on documenting service reports
  • Summary

System requirements

  • Windows XP (Service Pack 3), 7, 8
  • Internet Explorer 6 or later
  • Note:  This program will not run in Chrome, Firefox, or Safari.  It will not run on a Mac.  
DTA logo Produced for and in collaboration with the Dental Trade Alliance

 You can buy the individual disks, or you can buy the complete training set for a 30% savings.