Quality Risk Management - An ICH Q9 Training Course

Quality Risk Management - An ICH Q9 Training Course

Barcelona, Spain

Course No 16980


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Timur Güvercinci, Merck Group
Christof Langer,  OSConsulting
Aidan Madden, FivePharma
Dr Heinrich Prinz,  PDM Consulting
Dr Franz Schönfeld, GMP Inspector


This ICH Q9 training course deals with the practical implementation of the requirements. Individual examples will support you applying Quality Risk Management (QRM) principles in your Company.


After its finalisation, the Guideline ICH Q9 “Quality Risk Management” was implemented in the EU, the U.S. and in Japan.
In the course of implementing ICH Q9, the risk-based approach increasingly gained in importance. Before that, it was often the case that processes were defined, implemented and documented to the latest Detail.

Now, based on risk assessments, more flexibility is possible, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. QRM permits scientifically substantiated decision making based on a previously assessed risk.
Unfortunately many companies limit their whole QRM system only to the implementation of the FMEA method. But it is much more than this and QRM can really support the pharmaceutical industry in improving their processes and Performance.

Target Group

This course is designed for members of staff in pharmaceutical, biopharmaceutical and API industry’s production and quality units, who establish, manage and improve quality risk management Systems.


ICH Q9  Quality Risk Management
  • Basic Requirements
  • Comparison to ISO standards
How to implement Quality Risk Management in a pharmaceutical Company
  • The risk-based approach and its impact on key GMP processes
  • ICH Q9 in the context of ICH Q8 and ICH Q10
  • The implementation of  „quality risk management thinking and doing” on management and shop floor level (tools and experiences)
How to realise Quality Risk Management in a GMP Environment
  • An overview of the diverse techniques (FMEA, HACCP, FTA etc.)
  • Benefit of the tools
  • Examples from the production of  medicinal products and APIs
How to apply Quality Risk Management in Validation
  • Understand why the use of Risk Management in
  • Process Validation is expected
  • What is the benefit of using a Risk Management 
  • approach versus the traditional 3 batch validation
  • approach?
  • What does ICH Q9 mean with respect to Quality Risk Management in Validation
  • Benefits
  • Exercise
The Inspector’s View
  • Expectations
  • Integration in the Pharmaceutical Quality System
  • Examples for good and not so good practice
  • A problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.
Design of an Event Handling System based on a Quality System and Quality Risk Management Approach
  • QRM in the Quality System
  • Events (e. g. deviations, complaints etc.)
  • Risk Management Application
  • Outputs
Presentation and Workshop on Risk Management in the Supply Chain:
An interactive workshop to establish where to best concentrate your resources to maximise the assurance of a reliable supply chain:
  • Frequency of Supplier Audits based on Risk Assessment
  • Defining risk in the audit program
  • Compliance risk assessment
After the workshop you will be able to use or adapt the template to conduct a similar risk profile for your own facilities and third-party operations.

Interactive Session on Case Studies
The term “quality risk management” is used throughout the GMP guidelines. In this session you will get some practical advice and work with scenarios requiring a decision.

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