Sprecher
Richard M. Bonner, formerly with Eli Lilly, United Kingdom
Dr Helene Zuurmond, Pfizer, Belgium
Dr Heinrich Prinz, Apceth GmbH, Germany
Dr Thomas Schneppe, Bayer Pharma AG, Berlin, Germany
Zielsetzung
The Guideline ICH Q9 „Quality Risk Management“ was finalised in November 2005 (Step 5). Consequently, this guideline has been implemented in the EU, the US (FDA) and in Japan.
The ICH Q9 training course in hand deals with the practical implementation of the requirements. Individual examples help to show the application in the following GMP areas:
Validation
Change Control/Change Management
Auditing/Inspections
Quality Systems
As a complement to the lectures, the closing workshop offers the opportunity to practise Quality Risk Management techniques with a case study.
Zielgruppe
This event has been designed for quality assurance personnel. It also addresses staff from other departments, like e.g. production, engineering, quality control, and regulatory affairs.
Programm
ICH Q 9 Quality Risk Management
- Basic requirements
- Comparison to ISO 14971
- Practical Examples
- An overview of the diverse techniques (HACCP, FTA etc.)
- Access benefit of some tools
- Examples from the production of drug (medicinal) products and APIs
- Understand why the use of risk management in process validation is now expected
- What does the FDA expect for batch conformance prior to and post product approval
- What is the benefit of using the risk management approach versus the traditional 3 batch validation approach?
- What does ICH Q9 mean with respect to quality risk management in validation
- Learn why the quality risk management approach to validation will result in less ongoing process support during production
- The quality system
- Risk management principles
- Events (e. g. deviations, complaints etc.)
- Risk management application
- Outputs
- The risk-based approach and its impact on key GMP processes (GAMP®5,
- FDA Guidance on Process Validation, etc)
- 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)
- Understand how to assess risk between different operations
- Identify priorities for the audit
- Learn how to use a point system to assign audit priorities based on risk
- How to use a template to make a risk-based audit schedule
Learn how to create an audit schedule by looking at the various risk categories associated with the various operational activities within the differing units. This workshop will help you look across the different units from production operations, vendors, third-parties and laboratories, rank them by risk and then apply this to a template to create an audit schedule covering the next 3 years.
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
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