Tag Archive for FDA

Archiving Training Records

Q: Can you tell me how long I should keep training records and when to archive them? We manufacture active pharmaceutical ingredients (APIs) with an expiration date of five years. A: The rule of thumb is to keep training records…

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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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CAPA Definitions as Used by FDA and ISO

CAPA definitions and terms can sometimes be confusing. Nearly everyone stumbles over the proper use and application of the CAPA terms of corrections, corrective actions, and preventive actions. The following CAPA definitions clarify the differences and are consistent with interpretations…

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