GAMP®5 Second Edition - What’s Different - What’s New?
- Reasons for a Second Edition
- Critical Thinking
- Advancing Technology
- Enabling Innovation
- Changes from the original GAMP®5 – a section by section overview
- What has been retained?
- Significant revisions
- New Topics
- How will this affect current good CSV practice?
- Key Messages
- Expected improvements
IT Infrastructure / Cloud Computing
- Summarising Appendix M11
- IT Infrastructure changes in the 2nd editio
- General impact on CSV and GAMP®5 best practices
Agile Software Development
Software Tools
- Summary of new Appendix D9
- Enabling innovation, increasing quality
- Compliant selection and handling of tools for CSV
Critical Thinking
- What the industry oversaw (ignored?) during the last 20 years
- Enabling Innovation and GAMP®5 2nd Edition
- Quality Risk Management: the keystone process for Critical Thinking
- Practical application of critical thinking in projects and processes
GAMP®5 2nd Edition Impact on System Suppliers
- Differences between GAMP®5 1st and 2nd Edition
- Could system and equipment suppliers leverage critical thinking and CSA?
- Persistent expectations
- Supplier maturity: facilitating Leveraging Supplier Involvement
Artificial Intelligence and Machine Learning (AI / ML)
- Summary new appendix D11 & Life Cycle Approach
- Concept Phase
- Project Phase & supporting processes
Pros / Cons
- Individual statements from the speakers
- Panel discussion
Recording from 2 November 2022
Duration of the recording: approx. 5 h 40 min