Day 1

• Investigate the reasons for the GAMP® 5 version update
• Industry developments
• Regulatory drive including Quality Risk Management, ICH Guidance and integration into QMS
• Latest terminology and common themes including relationship between Qualification Terminology and GAMP® 5 activities
• Compare the differences between GAMP® 4 and GAMP® 5
• Cross referenced table of differences
• Look at key concepts
• Main article and contents
• Appendices
• Review the life cycle approach and phases, including: life cycle concepts; concept, project and retirement
• Project
• planning
• specification
• configuration and coding
• verification
• reporting and release
• support
• To include practical examples based upon GAMP® categories of software
• Operational phases including
  • Handover
  • CAPA
  • Change management
  • Security and system administration
• Introducing Quality Risk Management
• An overview of Quality Risk Management including:
• Integration to the QMS
• The process itself and links to ICH Q9
• Describe regulated company activities to assure computerised system compliance
• Elements to achieve compliance
• Policies and procedures, roles and responsibilities
• Training, managing supplier relationships, system inventories and specific activities
• Develop understanding of guidance on supplier activities
• View help for suppliers; non configured product, configured product and custom package
• Investigate supplier best practices

Day 2

• Consider guidance on efficiency improvements
• Specific points in determining objective user requirements
• Utilise risk assessment practice to determine life cycle activities
• Influence supplier input and maximise use of own documentation
• Effective testing and system handover
• Operational activities
• Review main article topic 4, Life Cycle Phases, related Management Appendices
  • M1 Validation Planning
  • M2 Supplier Assessment
  • M4 Categories of Software and Hardware
  • M5 Design Review and Traceability
  • M7 Validation Reporting
  • Investigate changes to appendices and also new management appendix M10
• View appendix M3 Science Based Quality Risk Management relative to article 4 and 5 in the main contents of the guide
• Roles and responsibilities
• Guidance and examples for different categories of systems

Day 3

• Research remaining appendices
• D2 Functional Specification
• D3 Configuration and Design
• D4 Incident Management
• D5 Testing relative to article 4
• Check revised appendices and new appendices
• D6 System Description
• D7 Data Migration
• Develop understanding of new Operational Appendices covering
• O1 Handover
• O4 Incident Management
• O5 CAPA
• O7 Repair Activity
• O12 System Administration
• Investigate the special interest topics appendices
• S1 Alignment of ASTM E2500
• S2 Electronic Production Records
• S3 End User Applications
• S4 Patch Management
• S5 Managing Quality within an outsourced IS/IT environment
• S6 Organisational Change
• Review of G1 GAMP® Good Practice Guides

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