Programme

Introduction to Integrated Qualification and Validation
Ralf Gengenbach

• Development of ECA´s Integration and Validation guideline

Modern Qualification and Validation from a European Inspector's point of view: ECA Good Practice Guide and the relation to EU GMP Annex 15
Dr Franz Schönfeld

• 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

Integrated Qualification and GMP Equipment Design: Two ECA guidelines in practice
Gert Moelgaard

• Quality Risk Management and Good Engineering Practice
• Qualification and Validation alternatives
• Supplier management challenges
• Qualification and Validation for the future

Equipment Categorisation – new chapter and appendix as a tool to streamline qualification
Maik Guttzeit

• Regulatory possibilities for using qualification approaches, which are adapted to relate risk
• On the way: The revised categorization chapter, what is planned?
• Appendix: template equipment qualification

Critical Aspects Risk Assessment (CARA) – new chapter to clarify risks
Rafeal de Souza

• The CARA concept in the equipment qualification life cycle
• Comprarison between Quality Risk Management and CARA

Case Study Customer Supplier Cooperation – A Project Example
Holger Frey

• Project description (Capex project with integrated Qualification Activities together with the supplier)
• Project milestones
• PQualification project together with the supplier
• Validation and Start-up

eValidation – How to overcome Challenges with Paper-Based CQV Approches
Denis Dreher

• Experience and Challenges with Paper-Based CQV Processes
• Understanding the Concept of a Paperless Validation System
• Differences between electronic Document Management System and eValidation Systems
• Efficient implementation of an eValidation Tool – Strategies and Best Practices

Paperless Validation and Qualification System Implementation and Experiences
Sunil Patel and Alejandro Parisi

• Goal and Benefits
• Standardisation of business processes and templates
• Steps in order to choose the right system: from a User Requirement to a validated system
• Global rollout
• Practical examples

Feedback to the Integrated Qualification and Validation Guide
Ralf Gengenbach

• Open questions
• Outlook