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

Collaboration to ensure that the supplier’s documentation can be used as qualification?

  • Purpose of Supplier Assessment
  • Supplier Oversight during Construction
  • Suitability Evaluation of Supplier’s documentation
  • Supplier Performance Evaluation

Feedback to the Integrated Qualification and Validation Guide 

  • Open questions
  • Outlook