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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; 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.