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In this session, the panelists will provide brief presentations on key topic areas of the GAMP 5 revision, including Critical Thinking; Applicability of iterative and incremental software development methods; IT infrastructure; Blockchain; Artificial intelligence and machine learning; and Computer Software Assurance. In addition, attendees will have the opportunity to engage in direct discussion with the primary authors of the material covering these topics.
In this session you will hear about how GAMP 5 Second Edition has had an impact on the pharmaceutical industry, the current FDA position on Computer Software Assurance (CSA) including how organizations are adapting to a CSA environment, the significant areas of progress and, conversely the remainin…
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 importanc…
Concurrent Session: **NEW** GAMP 5 Second Edition Roundtable | In this session, the panelists will provide brief presentations on key topic areas of the GAMP 5 revision, including Critical Thinking; Applicability of iterative and incremental software development methods; IT infrastructure; Blockcha…
In this session, attendees will learn how modern IT Infrastructure Management practices and technologies can be effectively utilised to maintain IT Infrastructure in a state of continuous compliance…