Introduction to Integrated Qualification and Validation
- Development of ECA´s Integration and Validation guideline until version 2.2
- What is new?
Integrated Qualification and Validation acc. EU GMP Annex 15: Inspector´s View
Dr Rainer Gnibl
- Qualification Life Cycle (Overview)
- Boundaries & Possibilities of Annex 15
- What is a must, what is a nice to have?
- Linking of Qualification & Validation possible?
- What GMP rules are important for contracting (overview)?
- GMP rules for electronic documentation from supplier? (Overview)
- How about equipment categorization to leverage qualification activities
ISPE Commissoning & Qualification Guide Version 2 (2019)
- ISPE Baseline guide 5 Update
- Key Aspects/features of the ISPE Baseline
- How do we do a GAP assessment of current practices vs the new BG-5?
- Implementation program for BG-5 and sustaining operations
- GAMP 5 2nd version
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?
Rolf Bauer & Dr Clemens Borkenstein
- Defintion, considerations and limits regarding remote testing
- Collaboration and alignment of equipment manufacturer and customer
- Checklist for preparations before / during and after a remote FAT
- Documentation of results and handling of deviations
- Show case project for remote test execution including “best of” video sequences
Equipment Categorisation – a tool to streamline qualification
- Regulatory possibilities for using qualification approaches, which are adapted to relate risk
- The revised categorization chapter, what is new?
- New appendix: template equipment qualification
Case Study Customer supplier cooperation – A project example from Merck Healthcare KGaA
- Project description (Capex project with integrated Qualification Activities together with the supplier)
- Project milestones
- Qualification project together with the supplier
- Validation and Start-up
Update Electronic Documentation in Qualification projects
- Requirements for electronic documentation in qualification
- Requirements related to Data Integrity
- The ALCOA principle
- Case study
- What does 3 C-Management mean?
- When to start with GMP?
- Ideal project course
- GMP-Doc´s interfaces
- Commissioning management slides
Overview about the Updates of the Working Groups
Speaker to be announced
- Contract group
- CARA group
Feedback to the Integrated Qualification and Validation Guide
Panel discussions about the way to electronic documentation in qualification Projects.