Скачать или смотреть How To Prepare for FDA Inspections

Steven Niedelman offers advice on how to prepare for an FDA inspection.

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Preparing for an FDA Inspection? Watch this Playlist of our FDA preparation videos:    • How To Prepare for FDA Inspections  

FAQ:

What is an FDA Inspection?

FDA conducts several types of inspections to help protect consumers from unsafe products: pre-approval inspections, routine inspections, and “for-cause” inspections to investigate a specific problem that has come to FDA's attention.

Why are inspections important?

Regulatory inspections are important to protect patient safety and assess the adequacy of site/sponsor quality systems. Inspections generally occur after the submission of data for marketing approval of an investigational drug.