The conference programme focusses on the implementation of integrated qualification and validation methods into daily practice.

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