Programme

Introduction to ECA´s Good Practice Guide Qualification and Validation

• Development of ECA´s Qualification and Validation Good Practice Guide
• Overview of Version 3.0

Knowledge Management in Validation Life Cycle: Inspector´s Expectations

• What does Knowledge Management mean in GMP environment
• Toolbox for management
• Which data are essential?
• Focus: Qualification & Validation
• How to assure lifecycle performance

GEP – the Basis for a Qualificatio

• 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?

Evolution of the Qualification and Validation Practices since its Inception

• ƒ General Qualification & Validation History
• First realization in the XX Century
• The US and EU guidances
  − the FDA 1983, 1987 and 2011 guides
  − the PIC/S basis
  − the EU Annex 15, 2001
  − the new Annex 15 is coming
  − Separation of the Qualification & Validation tasks
• Dispatching of the Qualification & Validation roles: OEM, Industry, Consultants
• Conclusion: Extension of the scope and extension of the qualificators/validators

AI – “Prompt”: Artificial Intelligence, qualify yourself! – Or How Else?

• Differences from conventional software or conventional computer-based systems
• The auditor and (draft) Annex 22 of the EU GMP Guide
• What is different from “normal” data management regarding data integrity? -Qualification/Validation as usual?
• What about the responsibility for AI results?
• How to control the AI Approaches?

User Requirement Specification: The Biggest Risk - or the Greatest Opportunity?

• The Fundamental Goals of a URS — More Than Just Paperwork
• Between Bestselling Novel and Critical Project Definition: The Intention of a URS
• Lean URS: Minimalist, Focused, Powerful
• Using AI as Co-Author: Smart Support or Risky Shortcut?

“Pixi-Booklet“ – an Easy Way to Share Qualification Information with Suppliers

• What is meant with “Pixi-booklet”?
• Why a Pixi-booklet for ECA´s Good Practice Guide Qualification and Validation?
• Example of a “Pixi-booklet”

Case Study: Lean VMP for Qualification and Validation

• Continuous Process Verification vs. Classical Approach
• Virtual VMP
• Jidoka-Approach for IPC – is it possible to automate revalidation?

Fleet Management – A New Streamlining Concept for Qualification?

• Primary Definitions
• Proposed Framework for Distributed Manufacturing
• Fleet Management
• Potential Benefits
• A centralised PQS
• Knowledge Management in a Fleet
• Examples out of practice