The conferences programme focusses on the implementation of integrated qualification and validation methods into daily practice. Different concepts will be introduced and discussed, and a workshop at the end of the second day gives participants the opportunity to get involved.

Introduction to Integrated Qualification and Validation
Ralf Gengenbach

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

Integrated Qualification and Validation acc. EU GMP Annex 15: Inspector´s View
Dr Rainer Gnibl

  • 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

ISPE Commissoning & Qualification Guide Version 2 (2019)
Jörg Zimmermann

  • ISPE Baseline guide 5 Update
  • Key Aspects/features of the ISPE Baseline
  • How do we do a GAP assessment of current practices vs the new BG-5?
  • Implementation program for BG-5 and sustaining operations
  • GAMP 5 2nd version

How suppliers work: Good Engineering Practice in Qualification
Ralf Gengenbach

  • Basic Engineering Workflows (CD, BD, DD – EPCMQ Projects)
  • Process-, Equipment Engineers and more (the full picture)
  • Key Documents in Engineering Processes
  • FAT, SAT and Commissioning
  • How a supplier can support qualification
  • Typical pitfalls?

Remote FAT/SAT
Rolf Bauer & Dr Clemens Borkenstein

  • Defintion, 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

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

Case Study Customer supplier cooperation – A project example from Merck Healthcare KGaA
Holger Frey

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

Update Electronic Documentation in Qualification projects
Igor Krasula

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

3 C-Management
Axel Heueis

  • What does 3 C-Management mean?
  • When to start with GMP?
  • Ideal project course
  • GMP-Doc´s interfaces
  • Commissioning management slides

Overview about the Updates of the Working Groups
Speaker to be announced

  • Contract group
  • CARA group

Six essential Mistakes in Qualification
Ralf Gengenbach

Feedback to the Integrated Qualification and Validation Guide
Ralf Gengenbach

  • Open questions
  • Outlook