Introduction to Integrated Qualification and Validation
- Development of ECA's Integration and Validation guideline
Integrated Qualification and Validation acc. EU GMP Annex 15: Inspector´s View
- 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
Modern Qualification and Validation from an Ex-FDA perspective
- FDA’s Process Validation guide
- Process Validation as a life-cycle approach
- Lessons learned from the FDA Process Validation guide
- International harmonization of process validation?
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
Remote FAT/SAT – Tools possible not only in a pandemic situation
- The new chapter in ECA´s Good Practice Guide
- How to organise remote FAT/SATs?
- Case studies
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: Case Study LAF
Supplier Contracts during Qualification
- Legal requirements on contracts
- What should be in a contract and what not
- How a contract can support the quality of cooperation
- New chapter contracting in ECA´s Good Practice Guide
- New Annex about contracting (checklist)
Case Study: Influence of pharmaceutical QA during renovation and new buildings
- How many QA is enough in technical projects?
- How to enhance a qualification project (implementation of FAT/SAT, equipment categorisation)
- URS: definitions regarding quality relevant and economic relevant requirements
- Complaints, deviations, changes during project life cycle
- Traceability of qualification activities during project life cycle
- Handover of an project to routine production
Electronic Documentation in Qualification projects – new Appendix
- Requirements for electronic documentation in qualification
- Case studies
Equipment Categorization – 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
Feedback to the Integrated Qualification and Validation Guide
- Open questions