Tuesday, February 21, 2012

How much GMP training is “enough”?

GMP Coaching, How much GMP training is “enough”? Fair...:

"Listen, lack of documented GMP training has been one of the most common FDA Inspection findings so far. “Documented” Training? Yes, the company must have an updated list on file of all training received by every employee.  Expect an FDA inspector to ask to see your training log during the course of the inspection (good reason to make employee GMP Training your top priority) If you don’t keep your training log up to date, the FDA will say that the training never happened. That’s their approach, so be ready."
'via Blog this'

Good points above.  Some training experts might suggest anything from 4-8 hours of training a year to meet "enough."  Also consider, if the company has more deviations, or 483 observations, then that might suggest the need for even more training hours.

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