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
Attendees from companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields, involved in:
- QA management
- Regulatory management
- Sales personnel
- Customer Service personnel
- Quality system auditors
- Consultants
