Tag Archive for Inspection

FDA Requirements for Source Data

Q: I’m trying to locate the source of the regulatory requirements to 1) maintain original source data as part of the official record and 2) maintain each copy of an executed qualification/validation protocol. Can you point me in the right direction?…

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FDA Expectations for Internal Audits

Q: What are FDA’s expectations for internal audits? For example, how frequently should we conduct internal audits? And what documents does FDA expect to see to prove we’re actually doing the audits? A: First of all, FDA expects you to…

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Download an EduQuest Advisory on Your Kindle

An EduQuest Advisory for two FDA compliance challenges are now available for immediate download on KindleTM readers (and Kindle apps on Ipads and other mobile devices). An EduQuest Advisory is a brief but comprehensive white paper that provides practical FDA compliance advice from…

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