Mr. O'Keefe has over 15 years of R&D management and IT consulting expertise, working with both top tier pharmaceutical firms, and early stage biotechs. Prior to Astrix, he established and led the R&D Consulting Solutions practice for Paragon Solutions/CGI Life Sciences, where he focused on helping drive adoption of business capabilities such as: submissions management and archiving; IDMP; electronic management of Trial Master Files and investigator interactions; and defining and implementing risk-based monitoring programs.
This session will review the methodology and things to consider in risk-based validation, to find the sweet spot between 100% requirements testing, and simply accepting the product vendor deliverables.
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