Programme

Introduction to Integrated Qualification and Validation
Ralf Gengenbach

• Development of ECA´s Integration and Validation guideline since version 2.2
• What is new?

Modern Qualification and Validation from an EU Inspector's View on Current Approach
Klaus Eichmüller

• Overview regulatory requirements
• Changes in Annex 15 for qualification activities
• In between: Cleaning Validation
• Process validation: Expections and weakness
• Perspective

Comparison of Equipment Qualification Guidelines – which one for which Purposes?
Ralf Gengenbach

• What is on the market regarding equipment qualification?
• What is mandatory and what is optional?
• How far are those guidelines and standards harmonized?
• Are there different guidelines for different purposes?

Update Critical Aspects Risk Assessment (CARA) Chapter
Rafael de Souza

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

Video-assisted FAT/SAT – The Update in the Guide
Rolf Bauer & Dr Clemens Borkenstein

• Definition, considerations and limits regarding remote testing
• Collaboration and alignment of equipment manufacturer and customer
• Checklist for preparations before / during and after a remote FAT
• Documentation of results and handling of deviations
• Show case project for remote test execution including “best of” video sequences
• What is new in this chapter

Update Equipment Categorisation – a Tool to streamline Qualification
Maik Guttzeit

• Regulatory possibilities for using qualification approaches, which are adapted to relate risk
• The revised categorization chapter, what is new?
• New appendix: template equipment qualification
• Examples
• What is new in the guide?

Electronic Documentation in Qualification Projects
Igor Krasula

• Requirements for electronic documentation in qualification
• Requirements related to Data Integrity
• The ALCOA principle
• Case study

Strategies to plan Qualification Activities in Life Science Projects
Pia Loris

• Qualification requirements in project plans
• GMP Qualification Requirements in Life Science Projects
• Potential Sources of Error during GMP Qualification
• Optimization of GMP Qualification Activities
• Examples

Audit and Inspection Findings regarding Equipment Qualification
Dominik Unglaub

• How deep is inspector's diving into the qualification topic?
• Which basic logic do they follow and which guidelines?
• Overview about some real inspection findings

Feedback to the Integrated Qualification and Validation Guide
Ralf Gengenbach

• Open questions
• Outlook