According to FDA’s 2015 enforcement statistics, Medical Device companies’ Product Complaint Handling system (21 CFR 820.198: Complaint Files) is the second most cited 483 with 294 Turbo EIR observations, representing 3% of all EIR observations. It is expected that FDA will continue to focus on the Product Complaint Handling system. Implementing and maintaining a robust and FDA compliant Product Complaint Handling system requires written procedures for complaint handling and record keeping that meet the requirements of 21 CFR 820.198, integration of the system in the overall Quality Management System (QMS), trained personnel for effective implementation and periodic monitoring.
The objective of the webinar is to enable participants to understand the key elements required for a compliant Product Complaint Handling system and apply the principles.
- Review FDA metrics & trends
- Sample 483 observations
- Definition of a complaint
- Requirements of 21 CFR 820.198: Complaint Files
- Key components of a compliant Product Complaint Handling system