How to answer questions from the inspector (FDA or EMA)

Manostaxx

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SOURCE: http://mastercontrolinc.blogspot.pt/2014/10/fda-vs-eu-inspections-similarities.html

Here is how to answer questions from the inspector from FDA or EMA:

  • Be concise; answer only the question that is asked
  • Answer honestly and openly
  • DO NOT volunteer information
  • DO NOT guess or speculate
  • DO NOT argue

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