Concurrent Session: **NEW** GAMP 5 Second Edition - An Overview |
Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software development, expanded use of software tools and automation, and modern approaches to managing infrastructure.
The session highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches.
Presentations delivered in this session will provide a foundation for the "New GAMP 5 2nd Edition roundtable" session which follows on after this session and will allow for a deeper dive into the detail of the Second Edition.
Retired Director Information Governance and Management,
Novartis Pharmaceuticals (retired)