Programme
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
