Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line.
Recalls, FDA Warning letters & even seizures could result.
This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.
Areas Covered in the Session:
- Complaints Definitions; FDA, EU & Canada
- How to Document Complaints & Adverse Events
- US & Foreign Regulatory Reporting
- Recall, Vigilance, Correction & Removals
- Enforcement Actions
Who Will Benefit:
- Regulatory Professionals
- Quality Engineers
- Manufacturing Engineers
- Operations Executives