ICH Q9 Training Course and ICH Q10 Training Course
Save up to EUR 600,- and book both courses simultaneously!

ICH Q9 Training Course and ICH Q10 Training Course Save up to EUR 600,- and book both courses simultaneously!

Heidelberg, Germany

Seminar Nr. 9292


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


ICH Q9 Training Course and ICH Q10 Training Course:

Richard M. Bonner, Formerly with Eli Lilly,United Kingdom
Dr Heinrich Prinz, Apceth GmbH, Germany
Dr Bernd Renger, Immediate Past Chairman of the European QP Association; Renger Consulting, Germany
Dr Thomas Schneppe, Bayer Pharma AG,Germany
Dr Helene Zuurmond, Pfizer, Belgium


ICH Q9 Training Course
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:
Change Control/Change Management
Quality Systems

As a complement to the lectures, the closing workshop offers the opportunity to practise Quality Risk Management techniques with a case study.

ICH Q10 Training Course
The International Conference on Harmonisation has published the Guidance ICH Q10 Pharmaceutical Quality Systems in June 2008. This Guideline has been transferred to European, US and Japanese regulation. Thus, all companies in these regions have to implement the key requirements of ICH Q10. However, the US FDA is still using their own Guidance for Industry (Quality System Approach to Pharmaceutical cGMP).

The implementation of these requirements have caused a number of questions. Among others ISO elements like continual improvement are new in the pharmaceutical industry. This training course has been developed to discuss the requirements and how they can be implemented in pharmaceutical industry.


ICH Q9 Training Course
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.

ICH Q10 Training Course
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.

In addition the topics will be further discussed in interactive Workshops.


ICH Q9 Training Course
ICH Q 9 Quality Risk Management
Basic requirements
Comparison to ISO 14971
Practical Examples

How to Realise Quality Risk Management in a GMP Environment
An overview of the diverse techniques (HACCP, FTA etc.)
Access benefit of some tools
Examples from the production of drug (medicinal) products and APIs

How to Apply Quality Risk Management in Validation
Understand why the use of risk management in process validation is now
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

Design of an Event Handling System based on a Quality System and Quality Risk Management Approach
The quality system
Risk management principles
Events (e. g. deviations, complaints etc.)
Risk management application

How to implement Quality Risk Management in a Pharmaceutical Company
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)

How to Make a Risk-based Audit Schedule
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

Workshop Quality Risk Management inPractic
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.

ICH Q10 Training Course
Introduction to ICH Q10
What are the key elements of ICH Q10?
Comparison with the FDA Guidance for Industry
How to comply with the Guidelines

Continual Improvement (Part 1)
Process Monitoring
Key Performance Indicators (KPIs)
Process Performance and Capability (link to Q8, Q9 and Process Validation)

Continual Improvement (Part 2)
CAPA Management as a tool for Continual Improvement
Change Management
Annual Reviews

Monitoring Quality Process Performance and Quality System
The Senior Management’s responsibility
How to perform Quality Management Reviews
Key Elements of a Review System

Responsibility of Senior Management
How to involve the management
Management Review
Practical Examples

Management of Outsourced Activities and Purchased Materials
How to choose, qualify and monitor Suppliers and Providers
Supplier Qualification as Part of the Quality System
Change of Ownership
Monitoring of the performance
Implementation of QMS - some milestones

All presentations will also include interactive Workshops!


GMP Seminare nach Thema