Bioequivalence and Bioavailability Forum

Hi ElMaestro!

❝ […] Would effectiveness of training in this regard then simply be to perform training and afterwards ask the trainees questions relating to the SOP and training content and predefine what a success rate is (like X correct answers out of Y questions or something)? Or would it also imply to somehow measure if they are applying the training correctly in practice? The latter would make sense to me. I assume that might somehow involve direct oversight of true production runs from QA staff??

Duno. As Susana Almeida recently said:

»Though it is easy to prove that an elephant is in the room – it might be very difficult to prove that an elephant is not in the room.«*

Reminds me a little bit on Russell’s teapot and the Flying Spaghetti Monster. Anyhow, given the deficiencies in FDA’s warning letter, training is the least important thing they should care about.

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• Actually a variant of Carl Sagan’s:
  »[The] impatience with ambiguity can be criticized in the phrase:
  absence of evidence is not evidence of absence.«