Complaint Handling – Best Practices webinar
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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
Course Director: DR. DAVID LIM
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