Complaint and Recall Management: A Compliant, Lean Program 2018

Topics

• Adverse Event Reporting
  • MDRs - Reporting Process, Reporting Requirements
  • Regulatory Overview: FDA, MDD
  • Exercise: Reportability of Events
  • Vigilance Reports - Reporting Process, Reporting Requirements
• Complaint Handling
  • Definitions
  • Regulatory Overview: FDA, ISO 13485 (including 13485:2016)
  • The Value of "Non-complaints"
  • Application of Definitions
  • Complaint Investigations
  • Complaint Triage and Handling
  • Contents of Complaint Form
  • "Closing" Complaints
  • Implementation of Risk Management into Complaint Handling
  • Complaint Review and Trending
  • Exercise: Complaint or Non-complaint?
  • Common Pitfalls and How to Overcome Them
• Recalls / Field Corrective Actions
  • Corrections and Removals
  • Regulatory Overview: FDA, MEDDEV, Health Canada
  • Recall Classifications
  • Market Withdrawal and Stock Recovery
  • Roles and Responsibilities

Who should Attend

• Regulatory personnel
• Customer Service (your "complaint taker")
• Sales and Marketing personnel
• Quality Engineering personnel
• R&D personnel
• Customer Service personnel
• Executive Management
• Manufacturing Engineering
• Quality system auditors
• Consultants