2 Day Course: Complaint and Recall Management - A Compliant, Lean Program - ResearchAndMarkets.com

DUBLIN--()--The "Complaint and Recall Management: A Compliant, Lean Program" conference has been added to ResearchAndMarkets.com's offering.

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints!

This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications.

Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Attention will be paid to the application of risk management to a complaint handling system, and a specific risk management system explained.

Agenda

Day 1 Schedule

Lecture 1: Introduction

Lecture 2: Complaint Handling

  • Regulatory Overview: FDA, ISO 13485 (including 13485:2016)
  • Definitions
  • Application of Definitions
  • The Value of "Non-complaints"
  • Complaint Triage and Handling
  • Complaint Investigations
  • "Closing" Complaints
  • Contents of Complaint Form
  • Complaint Review and Trending
  • Implementation of Risk Management into Complaint Handling
  • Common Pitfalls and How to Overcome Them
  • Exercise: Complaint or Non-complaint?

Day 2 Schedule

Lecture 1: Adverse Event Reporting

  • Regulatory Overview: FDA, MDD
  • MDRs
  • Reporting Process
  • Reporting Requirements
  • Vigilance Reports
  • Reporting Process
  • Reporting Requirements
  • Exercise: Reportability of Events

Lecture 2: Recalls / Field Corrective Actions

  • Regulatory Overview: FDA, MEDDEV, Health Canada
  • FDA Regulations
  • EU Requirements
  • Competent Authority Reportable Event
  • Reporting Requirements
  • Corrections and Removals
  • Market Withdrawal and Stock Recovery
  • Recall Classifications
  • Roles and Responsibilities

Lecture 3: Q&A - Conclusion

For more information about this conference visit https://www.researchandmarkets.com/research/7gfx3s/2_day_course?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Medical Devices

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Medical Devices