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Best Practices: Abstract

"How to Resolve Controversial QA Findings "

When QA performs its in-phase inspections, review of reports, and annual facility-wide inspections, there is the possibility that the Study Director or Principal Investigator may take exception to some findings.  These controversial findings present a problem on several levels: how to resolve them satisfactorily, who is responsible for managing the resolution, and how long it is acceptable for them to remain open and unresolved.  This article presents a rational explanation of how the process should go and suggestions for obtaining successful resolution and close out.

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David L. Scharberg
President, Pharmaceutical Outsource Soulutions, Inc.
Phone: (408) 557-9278
e-mail: david@pharmoutsource.com

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