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Root Cause- Is/ Is Not Tool

 

FEATURED WEBINAR:

Best Practices for Investigating Deviations

 

 

DATE:  Wednesday February 27, 2019

TIME: 10 am PST/ 1 pm EST

PRESENTER: Danielle DeLucy

DURATION: One Hour

Overview:

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations.  Learn how to identify and avoid potential pitfalls during deviation investigations.

LEARNING OBJECTIVES:

    • Review of FDA and Regulatory Requirements for Investigations
    • What is the definition of a Deviation?
    • Types of Deviations/Identification of Deviations
    • Conducting the Investigation
    • Interviews – dos and don’ts
    • Source Documents/Evidence
    • Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
    • Key Elements of the Investigation Report

PRICING

Choose to attend only the Live presentation, or order the On-Demand recording to watch at your convenience! All On-Demand Webinars are viewed through ePath, the PathWise online learning management system.

Interested in group pricing? Have  questions about PathWise Webinar offerings? Contact us!

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ON DEMAND LIBRARY

PathWise has a library of over 20 quality system presentations of previously recorded webinars for you to view!