Richard M. Bonner, ECA
Dr Heinrich Prinz, Apceth GmbH & Co. KG
Dr Thomas Schneppe, Bayer HealthCare AG
Dr Franz Schönfeld, GMP Inspector, Germany
Dr Helene Zuurmond, Pfizer
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.
This course is designed for all persons 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
How to implement Quality Risk Management in a pharmaceutical Company
- Basic Requirements
- Comparison to ISO standards
How to realise Quality Risk Management in a GMP Environment
- 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 apply Quality Risk Management in Validation
- An overview of the diverse techniques (FMEA, HACCP, FTA etc.)
- Benefit of the tools
- Examples from the production of medicinal products and APIs
The Inspector’s View
- 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
Design of an Event Handling System based on a Quality System and Quality Risk Management
- Integration in the Pharmaceutical Quality System
- Examples for good and not so good practice
- QRM in the Quality System
- Events (e. g. deviations, complaints etc.)
- Risk Management Application
A problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.
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
- 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.
Workshop 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.