Complaint and Recall Management: A Compliant, Lean Program 2018 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 2018 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
