Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities

The Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities is a webinar that covers topics such as:

  • Medical Device and Drug Complaint Handling Requirements (US)
  • Complaint Definition and Sources
  • Reportable Events
  • Interrelationship of Complaint Handling, CAPA, Change Control, Adverse Event Reporting and Recalls
  • What in Itself is a Reportable Event
  • When Does a Complaint Become a Reportable Adverse Event
  • Voluntary and Mandatory Reports, and Reporting Timelines
  • How Does User Error Relate to Adverse Event Reporting
  • What May Trigger a Recall During the Complaint Investigation
  • Complaint Handling Life-Cycle Process (including an example that embraces activities related to above five bullet points)
  • Challenges
  • Recall Classifications
  • References
  • Conclusion

The Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities is intended for:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Quality Control Departments
  • Complaint Handling Departments
  • Manufacturing Departments
  • Operations Departments
  • Engineering Departments
  • Process Development Personnel
  • Design Engineers
  • Customer Service Personnel
  • Service Technicians and Engineers
  • Sales Representatives

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