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2021 ISPE Annual Meeting & Expo

Concurrent Session: Digital Innovation - Ensuring Quality and Regulatory Compliant Solutions


Nov 1, 2021 1:00pm ‐ Nov 1, 2021 2:30pm


Description

Concurrent Session: Digital Innovation - Ensuring Quality and Regulatory Compliant Solutions|This digital innovation session allows attendees to discover how to cost effectively/efficiently validate and ensure the quality of their machine learning (ML) and software automation projects, while collecting and establishing the necessary evidence to withstand regulatory scrutiny. From a newly formed GAMP5 framework to computer systems/software assurance for automation, this session provides easily understandable and practical approaches behind the “mystery” of compliance for such novel digital technologies. Not only does the session give you tangible information to use in your next project, but it also breaks it down into the details you need. This includes ML as a sub-component of your overarching system(s), recommended risk-based life cycle deliverables, and right-sized scalable efforts to put your time and money where it matters most.

Leader/Speaker(s):

  • Eric J. Staib, Vice President of Compliance & Quality Management, Signant Health

Session Leader(s):

Speaker(s):

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