Conference Description:

This webinar will provide approaches to setting up an internal complaint handling system that ensures compliance with all GMP requirements. The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation and response to complainants.

Areas Covered in the Session :
Review of GMP requirements for complaint handling
Types of complaints that may be received
Tracking the complaint from time of receipt
Initiating and performing a complaint investigation
Review of the complaint and investigation
Preparing a response to the complainant
Preparation of an associated SOP

Who Should Attend:
Regulatory Affairs Departments
Compliance Departments
Quality Assurance Departments
Quality Control Departments
Manufacturing Departments
Clinical Operations Departments