FREE ON-DEMAND WEBINAR
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!