Developing and Maintaining an FDA Compliant Complaint Handling Process

An effective complaint handling process is essential for ensuring patient safety, maintaining product quality, and staying compliant with FDA regulations. In this webinar, Sarah Lacey Robbins, Senior Quality Manager at Rook Quality Systems, will walk you through the key elements of a compliant complaint handling system, common pitfalls to avoid, and best practices for integrating feedback into your quality management system. Whether you're building a process from scratch or looking to improve your current system, this session will provide actionable insights to strengthen your approach. What You'll Learn: Key FDA requirements for complaint handling under 21 CFR Part 820 How to distinguish between complaints, reportable events, and service requests Best practices for complaint intake, investigation, and documentation Tips for integrating complaint trends into CAPA and risk management Common mistakes companies make—and how to avoid them Chapters: 00:00 – Introduction of the Presenter, Sarah Lacey Robbins , Rook Quality System 02:45 – FDA Requirements For Medical Device Complaints 03:17 – Complaint Files 05:36 – Complaint Handling Process 08:22 – Medical Device Reporting (MDR) 13:10 – Corrective Actions & Preventive Action (CAPA) 15:51 – Complaint Closure 16:54 – Complaint Trending & Management Review 17:11 – Best Practices 19:25 – Questions