October 19, 2023

Complaint Handling: How to Avoid the #3 Most Cited Reason for 483 Observations

Improper complaint handling lead to 11% of 483 observations by FDA in medical device company inspections is 2022 (here). Even more depressing: this statistic has remained the same for 16 of the last 17 years!

So why do companies get so many 483 observations and why do they keep getting them? Are we fulfilling Einstein’s definition of insanity, i.e. doing the same thing over and over and expecting different results? Common sense dictates if we don’t identify the root cause of a problem, any solution will be a Band-Aid at best! In other words, practice does not make perfect… Rather, perfect practice makes perfect!

Having an effective complaint handling system is important from both a regulatory and quality perspective. But can we assume if our complaint handling system meets the regulatory and quality requirements, that it’s effective or that it’s working? Absolutely not!

Using the case study approach, regulatory expert Michael Drues, Ph.D. will help participants learn best practices to avoid timely and costly mistakes as well as creative ways to use complaint handling to their advantage!

Watch the webinar

Complaint Handling: How to Avoid the #3 Most Cited Reason for 483 Observations
This presentation will use the case study approach to take a broad look at medical device complaint handling, including:
  • What constitutes a complaint?
  • What do you do with complaint information?
  • How does the broad problem of device under-reporting impact complaint handling?
  • How do you properly and adequately investigate complaints to avoid 483’s?
  • Can complaints be positive?
  • What are the complaint handling challenges for the future?
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
Register Now  

Hosted by

Lisa Van Ryn round
Lisa Van Ryn

Medical Device Guru,
Greenlight Guru

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

About Vascular Sciences

Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996.

These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH).

Visit their website to learn more.

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