AS – Effective Root Cause Analysis for a Compliant Quality Management System

March 20, 2018 @ 10:00 am – 11:00 am

By Ajit Basrur


Stay Out of the FDA’s Crosshairs

Mistakes aren’t uncommon in manufacturing, but when a mistake occurs in medical device manufacturing, it can be devastating and even deadly. When a problem with a medical device arises, the appropriate response is to dig deep to find and fix the root cause. After all, the goal is to prevent the error from repeating.

Did you know that for the past 15 years, the number one reason for FDA 483 Observations and Warning Letters is failure to implement a Corrective and Preventive Actions (CAPA) process?

Don’t be a U S Food and Drug Administration (FDA) statistic: Learn how to avoid the same fate in this information-packed webinar. Join expert speaker Ajit Basrur as he walks you through the Root Cause Analysis and CAPA processes for addressing medical device defects. Learn how to: identify weaknesses in your system, develop a logical approach to problem-solving, take remedial actions to strengthen your processes, and put permanent solutions in place—all of which will go a long way toward ensring your organization’s success now and in the future.

After attending this audio event, you will have a clear understanding of Root Cause Analysis and CAPA requirements. By effectively identifying the root cause, you’ll be able to address all the different factors causing an issue and the process by which you can prevent the problem from recurring. You’ll also learn how to leverage an effective Root Cause Analysis and CAPA process to make your quality management system robust!

Session Highlights

Here is a taste of what you will uncover:

  • Learn the background and key definitions of CAPA and related FDA regulations.
  • Gain a clearer understanding of FDA, ICH, and ISO requirements, so you don’t get into hot water with the feds.
  • Discover Quality System Inspection Techniques (QSIT), Nonconformity, and CAPA Inputs.
  • Simplify your efforts with Root Cause Analysis tools, such as: 8-Disciplines (8D), the 5 Whys, the Fishbone (Ishikawa) Diagram, and Brainstorming.
  • Learn from examples of Root Cause Analysis and CAPA processes in action.
  • Understand how to take a risk-based approach and stay compliant with FDA regulations.
  • Discover how to avoid being slapped with FDA 483 Observations and Warning Letters.