This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received.
You will learn about the key components in managing complaints such as tracking the complaint from time of receipt to completion, initiating and performing a complaint investigation, evaluating the complaint for medical device reporting, final review of the complaint and investigation and preparing a response to the complainant.
Why should you Attend: The information obtained in this webinar 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. Attend to learn the approaches to setting up an internal complaint handling system that follows all GMP requirements, from a small business perspective.
Areas Covered in the Session:
Review of GMP requirements for complaint handling per 21 CFR 820.198
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
Evaluation of complaint per 21 CFR 803
Preparing a response to the complainant
- Quality Assurance Personnel
- Quality Control Staff
- Clinical Operations
- Regulatory Affairs Personnel
• Quality Assurance Personnel
• Quality Control Staff
• Clinical Operations
• Regulatory Affairs Personnel