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 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

 

 

 

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