• 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

This course is targeted to professionals involved in:

• Regulatory Affairs Professionals
• Quality Assurance Managers
• Quality Control Managers
• Engineers and Engineering Managers
• Quality Engineers
• Product Developers
• Manufacturing Managers
• Compliance Officers
• Pharmacovigilance