Sprecher
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, Berlin, Germany
Zielsetzung
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.
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.
In addition the topics will be further discussed in interactive Workshops.
Bonus Material for all participants of the ICH Q10 Training Course
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.
Programm
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
All presentations will also include interactive Workshops!
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