Quality Risk Management Training

Training overview
Corporate / Group Training
2 days
Start dates
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Course description

Quality Risk Management Training

This Quality Risk Management training course is designed to help effectively manage risks as a formalized system. Course participants will learn principles and applications as they apply to ISO 14971 and ICH Q9 guidelines, and become acquainted with the necessary tools, techniques, tips and skills for effective implementation of risk management. Quality Risk Management Training will also help support adherence to ISO 13485:2016, with the increased referencing of risk management and risk assessment.

Attendees of the PathWise Quality Risk Management Training course will learn how to:

  • Demonstrate what is important about your business and safe for customers.
  • Identify the components of the quality risk management process.
  • Understand roles and responsibilities in risk management.
  • Discuss hazards and risks in designs, systems, and processes.
  • Appropriately apply Quality Risk Assessment tools.
  • Connect risk review to your company’s quality system processes.
  • Provide a documented, approved rationale for your decisions.
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Who should attend?

Quality Risk Management Training is appropriate for individuals working with pharmaceutical, medical device, or biologics who are regularly called upon to mitigate risk to the quality system. Examples include research and design engineers, quality assurance, and regulatory and compliance personnel. 

Training content

The Quality Risk Management Training course contains the following modules:

1. Quality Risk Management Introduction

  • Define risk and identify roles in risk management. Explain current regulatory requirements for risk management. Identify the components of the quality risk management process.

2. Quality Risk Management Process and Tools

  • Initiate a risk project and identify appropriate personnel for a quality risk management team. Then, apply and establish risk acceptance criteria for the project using tools such as, process maps and brainstorming. Step-by-step walk through of the regulations and risk process including detailed risk assessment and control activities. In depth activities focus on risk identification, analysis, evaluation, reduction and acceptance. Ensure the risk management process is effective, tracks events that might impact the original risk management decisions. Also, learn expectations for monitoring and reviewing risk.

3. Failure Mode Effects Analysis (FMEA) Tool: 

  • The FMEA tool is often the first step of a system reliability study. Itinvolves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet.

4. Fault Tree Analysis (FTA) Tool

  • The FTA is a tool used in a risk based system to identify any pertinent factors that contributed to an undesired event. The tool is an effective tool in order to identify potential causes or pathways to the event or failure.

Why choose PathWise?

Founded in 1998

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About PathWise


In a globally regulated life science industry, PathWise provides proven methodologies in quality and compliance through hands-on and practical solutions that ensure compliant, effective, and efficient quality systems. PathWise focuses on a solutions-based approach to solving client issues. We help...

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Average rating 5

Based on 8 reviews.

Lots of good applicable info and examples; good discussion. I appreciatedthe emphasis that there is more than 1 right way to approach aspects of FMEA.
I enjoyed practicing both FTA and FMEA in person. [The instructor] presented the material very well, but allowing us to try to use each of them ourselves while she was there to guide us and answer questions when we got stuck was essential.
It was my first official introduction to quality risk management. The concepts covered in the course were ones which were a part of my everyday work, but it was great to have an official introduction.
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