Programme

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
• Outlook