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?

A Qualification Case using elements of the new ECA´s Good Practice

  • Content of the guideline
  • about necessary activities and explanations/interpretations
  • how to establish the basis for understanding of involved parties
  • the success and the areas for impromvent in the future

ISPE Commissoning & Qualification Guide Version 2 (2019)

  • Why to change the Baseline vers 1
  • Key Aspects of the ISPE Guide
  • How do they relate to each other

Case Study: Water System

  • Risk workshop
  • DQ the central qualification element
  • GEP
  • ECA-Guideline

Equipment Categorisation – one way to streamline  Qualification

  • Equipment categorization helps to select an appropriate effort for qualification activities and helps to avoid excess work
  • What is the perfect timing for equipment categorization?  during design phase in a customer supplier partnership
  • Categorisation of Manufacturing Systems
  • Questionnaire for a categorisation

Qualification terms – are Babylonian times back?

  • What activities are required in qualification?
  • What are the terms used for it (EU, US)?
  • How are the different terms (FAT, SAT, Testing, Qualification, Verification) related?
  • How to solve the problem in daily projects?
  • The framework: Good Documentation Practice /Good Engineering Practice

Case Study: Risk Managed Qualification in Capital Projects

  • Why does capital project delivery need to change
  • What are the key principles of a project delivery
  • How risk managed qualification is embedded in the Capital projects and what are the steps and relevant content (from requirement to release)
  • How supplier can create value  

Qualification and Validation: An integrated approach

  • Process Qualification - the „marriage“ of qualification and process validation
  • Development as basis
  • Integration of critical process parameters into qualification
  • The real goal is Process Validation/PPQ
  • Key performance indicators
  • Equipment qualification: view of a pharmaceutical company

Case Study: Update – Transforming Novo Nordisk´s qualification and validation concept to focus on GEP and supplier collaboration

  • The transition from Traditional qualification to a Science-and Risk-based integrated CQV process
  • What is good quality in qualification and validation
  • Core priniciples of Novo Nordisk
  • Tailor-made project execution based on risk

Electronic Documentation in Qualification projects – first ideas   

  • Scanned classical paper qualification documentation vs. tests being prepared, excecuted and documentated in electronic format
  • Requirements for electronic documentation in qualification

Feedback to the Integrated Qualification and Validation Guide   

  • Open questions
  • Outlook