ICH Q9 and ICH Q10 Training Courses Save up to EUR 600,- and book both courses simultaneously!
Speakers
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
Objectives
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:
- Validation
- Change Control/Change Management
- Auditing/Inspections
- Quality Systems
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.
Target Group
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.
Bonus material for all participants
Quality Management Manual of a fictive Company on CD-ROM – free of charge for all participants of the ICH Q10 course
The Quality Management Manual of the fictive company “Example” does not only take into consideration the quality assurance system (QA System) as required by the GMP regulation but also the requirements of the international standards EN ISO 9001: 2000 on Quality Management Systems and EN ISO 13485: 2003 “Quality Management Systems – Medical Devices – Requirements for Regulatory Purposes”. The Quality Manual was developed by a task force of the German Medicines Manufacturers Association. The content is structured according to ISO 9001. In the appendix of the publication you will find exemplary job descriptions, e.g. for the Qualified Person, Head of Production and Head of Quality Control. Further examples include forms for the review by the management and a process flow chart.
ICH Q10 versus ISO 9001-2015 Matrix
As part of the conference binder the participants will also receive a matrix which compares the ICH Q10 Guideline and the international standard on quality management ISO 9001. This matrix is helpful to identify areas that are not covered in one of the two documents.
Programme
ICH Q9 Training Course
ICH Q9 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.
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
- Process Monitoring
- Key Performance Indicators (KPIs)
- Process Performance and Capability (link to Q8, Q9 and Process Validation)
- CAPA Management as a tool for Continual Improvement
- Change Management
- Trending
- Annual Reviews
- The Senior Management’s responsibility
- How to perform Quality Management Reviews
- Key Elements of a Review System
- How to involve the management
- Management Review
- Practical Examples
- 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
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
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