Eva Baumgartner, Syntacoll
Dr Berthold Düthorn, Syntegon
Ralf Gengenbach, gempex
Gert Moelgaard, Moelgaard Consulting
Rafael de Souza, Pharmaplan
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.
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.
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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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
Recording from 08. June 2021
Duration of the recording: approx. 04 h 05