Speaker: Susanne Manz
Date: 14th November 2017 
Time: 10:00 AM Pacific | 1:00 PM Eastern
Duration: 90 Minutes
To register visit us at - ;

Description :

Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webinar will give you insights and lessons learned from an industry expert with over 30 years’ experience. You will learn how to get permanent resolution to your serious quality problems.

CAPA is the corner stone of an effective Quality System for Medical Device companies. However, it is still the number one cause of 483 and Warning Letter Observations. Without an accurate root cause analysis it is impossible to correct and prevent quality and compliance issues. Many companies struggle with inadequate root cause analysis resulting in on-going quality and compliance problems. This webinar will help you improve your root cause analysis leading to real and lasting improvements.

Objectives :

FDA Expectations
A Methodical Process for Root Cause Analysis
Root Cause Analysis Techniques
Do's and Don'ts
Myths of Root Cause Analysis
Documentation Expectations

Topics :

    Build the right team
    Develop a problem statement
    Data Collection
    Analysis Tools and Techniques
    How to Verify your Results