e-Learning: Risk management | EU GMP Guideline Part III




Risk management: from identification to monitoring of risks

How exactly does risk management work? From the identification of risks to their monitoring. This PTS e-Learning module increases your competency in the area of risk management.



Supplier Risk Managament is a must!

Risk management is required in more and more areas according to the EU GMP Guide for more and more fields. This means that risk management is not voluntary, but a definite must. In this e-Learning module, you will learn the basics of risk management according to ICH Q9, which is contained in Part III of the EU GMP Guideline, and how you can implement risk management in your own company. The e-Learning module provides you with numerous application possibilities and shows the advantages of the instrument risk management.



  • Risk management, what is it? From the identification of risks through the assessment to their monitoring. What is risk management good for?
  • Is risk management necessary?
  • Overview of the risk management process
  • Fault Tree Analysis (FTA) for risk identification
  • The Failure-Mode and Effects-Analysis (FMEA) for risk analysis
  • Risk communication and risk monitoring
  • Documentation
  • Areas of application of risk management
  • Final assessment (optional)


  • You will learn the individual steps of the risk management process according to the ICH Q9 guideline, which is contained in Part III of the EU GMP Guidelines.
  • In the module the Fault Tree Analysis (FTA) and the Failure-Mode-Effects-Analysis (FMEA) are shown as an example.
  • You will refresh your GMP knowledge from already completed training courses.
  • You will complete a final assessment to obtain a certificate.

Target groups

  • Employees who need to manage risk management processes
  • Employees who are involved in risk management processes
  • Employees who have to deal with questions on risk management in quality units
  • Persons who would like to get an overview of risk management
  • Suitable as initial training, refresher training or retraining

Special features

  • Interactive exercises
  • Learn at your own pace
  • From your workplace
  • Glossary with helpful terms and explanations
  • With certificate

Industry sectors

  • Medicinal products
  • Active ingredients
  • Toll manufacturers
  • Contract laboratories
  • Market
  • Logistics


Anna Diehl, PTS Training Service

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