GMP Inspectors are entitled to participate at no costs. For registration purposes, please send an E-Mail with your full contact details to info@gmp-compliance.org
Sprecher
Eva Baumgartner, Syntacoll
Dr Berthold Düthorn, Syntegon
Ralf Gengenbach, gempex
Gert Moelgaard, Moelgaard Consulting
Rafael de Souza, Pharmaplan
Dr Berthold Düthorn, Syntegon
Ralf Gengenbach, gempex
Gert Moelgaard, Moelgaard Consulting
Rafael de Souza, Pharmaplan
Zielsetzung
A team of pharmaceutical companies, engineering companies and suppliers have developed ECA´s Integrated Qualification and Validation Guide over 3 years. Since autumn 2020 the version 1.0 is available. The key for a successful qualification project is the “hand-in-hand” work from suppliers and customers together. With the integration of Good Engineering Practice (GEP) into qualification activities GEP-tests can be used also for the qualification phases – without retesting. This is one of the core concepts in the guide . With this course the practical “how to do” will be explained with “real-life” case studies.
Hintergrund
Almost 30 years after the coming into force oft he EU GMP Guide in 1992 equipment qualification is still often a miracle. Qualification projects overrun scheduled time limits. Failures are discovered in the IQ and OQ exercises. To fix this and the deviation reports extend the time limits again. A non-harmonized terminology causes one of the main problems, especially when it comes to the integration of good engineering practice into qualification. But on the other side is the integration of good engineering practice activities a key factor for qualification fast-track projects. How can this come together? This is the content of ECA´s Integrated Qualification and Validation Guide.
Zielgruppe
Everyone who may be influenced by the Annex 15 revision and FDA Process Validation Guidance regarding Qualification/Verification and Process Validation activities and want to see how the guide can be implemented in practice.
Technical Requirements
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Overview: Integrated Qualification and Validation:Good Practice Guide from ECA
- Development of ECA´s Integration and Validation guideline
- Main content
- Comparision to other qualification guides
How suppliers work: Good Engineering Practice in Qualification
- Basic Engineering Workflows (CD, BD, DD – EPCMQ Projects)
- Process-, Equipment Engineers and more (the full picture)
- Key Documents in Engineering Processes
- FAT, SAT and Commissioning
- How a supplier can support qualification
- Typical pitfalls?
Cooperation between customers and suppliers on Integrated Qualification and Validation
- Importance of Project Quality Plan (PQP) as upfront clarification document
- Agreement of scope of supply and services – task for both contractual partners
- Technical documentation, Test documentation and execution - the effect of work-shops for common understanding and agreement
- Importance of Qualification Project Management - Collaboration spirit as key success factor
ECA Q&V Guide and tools: Risk-based qualification from URS to PQ
- Critical Aspects Risk Assessment (CARA) and its 3 steps
- Interface between Product and process requirements (PPURS) and URS
- CARA and the “red thread” of user requirements
- Support C&Q tools: Use of Test Matrix (TM) and Requirements Traceability Matrix (RTM) from DQ to PQ
ECA Q&V Case Study: Fast and effective project execution with suppliers
- International standard, common language with suppliers
- Using the best ideas in our company
- Categories of equipment: benefit during qualification
- What would we expect from our suppliers?
- Integrated Qualification and Validation from a pharma perspective
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