A One and Half Day COMPREHENSIVE & INTERACTIVE Course with Workshops and Discussions ON:

- Definition of complaints and Complaint
Handling pitfalls
- Distinguishing between different types of complaints
- Post Market Surveillance to improve risk management
- Regulatory Expectations
- APR ‘s and the CFR Requirements
- International and domestic requirements for complaints and recall
- Development of Procedures for Managing Complaints
- Setting up a System for Complaints Handling
- Implement and Management of Complaints Handling System
- Effectiveness of the Complaint Handling System
- Type of Data Required and analysis of results, ensuing to possible product change
- Managing Recalls and Warning Letters
- Changes required after investigation of non-conformance, complaint resulting in recall