Are You Required to Validate Social Media Tools?

Q: I took your course on FDA Auditing of Computerized Systems and Part 11/Annex 11 last year and often refer back to the material when solving compliance questions. But here’s a new one: many companies are now using Facebook, Twitter,…

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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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Complaint Investigation: Recommended FDA Time-Frames

Q: I have a question about complaint investigation. What does FDA consider “timely” in terms of closing investigations of complaints? A:  A minimum of 30 days after becoming aware of the complaint — that’s how long you have to determine if…

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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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