Topics
- Establishment of complaint handling program
- FDA and ISO requirements for complaint handling
- ISO-specific implications of complaint handling
- What constitutes a complaint
- Complaint trending and reporting
- The roles of investigation and corrective action in complaint handling
- Application of risk management to complaint handling program
Who should Attend
Delegates from Diagnostic, Medical Device, Biologics and Pharmaceutical fields involved in QA Management, Regulatory Management, Sales, Customer Service and Quality System Auditing.