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Root Cause Analysis and CAPA

CAPA 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.

  • 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

When

14 Nov 2017 @ 01:00 pm

14 Nov 2017 @ 02:30 pm

Duration: 1 hours, 30 minutes


Where


Organised by

GRC Training Solutions (deactivated)

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