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