Complaint and Recall Management: A Compliant, Lean Program


Complaint and Recall Management: A Compliant, Lean Program is a conference that covers topics such as:

  • 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

Complaint and Recall Management: A Compliant, Lean Program brings together:

  • 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

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Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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