Complaint and Recall Management: A Compliant, Lean Program 2017

Complaint and Recall Management: A Compliant, Lean Program 2017 is a conference that covers topics such as:

• 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
• Adverse Event Reporting - Regulatory Overview: FDA, MDD
• Common Pitfalls and How to Overcome Them
• Vigilance Reports
• MDRs
• Corrections and Removals
• Recalls / Field Corrective Actions - Regulatory Overview: FDA, MEDDEV, Health Canada
• Recall Classifications
• Market Withdrawal and Stock Recovery
• Roles and Responsibilities