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NEW!
FDA Compliance Seminar:
2-Day Seminar: Overview Content
Computer Validation life cycle and documentation:
Commonalities in Risk Base philosophies:
Risk based workshop:
Instructor For more information or to register, please contact Karen von Sneidern at (978) 934-2473 or email Karen_vonsneidern@uml.edu |
UMass Lowell Continuing Studies, Corporate & Distance Education
lay out the basic validation methodology from the
Validation Master Plan, requirements documentation and testing protocols
(IQ, OQ and PQ), and will cover validation methodology which is a
vehicle for documenting the fit for intended use. It will also meet
current regulations by building upon existing industry good practice in
an efficient and effective manner. Participants are given an overview of
the computer systems compliance life cycle and they will learn the FDA’s
approach on Risk management and how to logically and pragmatically apply
the FDA’s new line of thinking with industry practice. Participants of
this course will walk away with a good understanding of the validation
life cycle and how to implement testing for computer systems. The
participants will also leave with an understanding of the risk based
approach and how it can be applied to their current jobs.
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Continuing Studies, Corporate & Distance Education