FMEA: The Ultimate Guide for Successful Risk Mitigation for Pharma and GMP

This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) is dedicated to GMP and pharma professionals. It will help you master one of the most vital instruments in your risk management toolbox.

topics Covered

FMEA Overview

Understand what is FMEA, why and in what cases you should use it.

Scoring Systems

Learn about different FMEA scoring systems and how to customize them to your organization.


Get familiarized with the term "as low as reasonably practicable" and learn how to use it in combination with FMEA.

Step by Step Tutorial

Follow the detailed explanations of how to conduct each step of the FMEA with essential insider tips.

Author spotlight

Yan is the founder and managing director at Qualistery GmbH. Through his vision, the company takes complex GMP topics and transforms them into engaging and enjoyable GMP training videos and training programs that captivate the audience.

As a result, GMP professionals retain more information, which they can successfully use in their workplace. This is highly beneficial for the employer as for the career of employees.

Yan Kugel

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