Programme

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