FDA Internal Complaint Handling

Why Should You Attend:

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.

Attend to learn the approaches to setting up an internal complaint handling system that is in compliance with all GMP requirements.

Areas Covered in the Webinar:

• 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 Will Benefit:

This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to good manufacturing practices.

• Quality assurance personnel
• Quality control staff
• Clinical Operations
• Regulatory Affairs personnel

Kelly Thomas
Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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