On November 23, 2016, the Food and Drug Administration (FDA) published a revised draft guidance for Submission of Quality Metrics Data. The guidance includes significant changes to the earlier quality metrics draft guidance issued by the agency on July 28, 2015.
A look at making GMP training more engaging and meaningful — to benefit both the business and its personnel.
What specific skills do managers and supervisors need to be successful in a GMP environment?
Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick. Every company wrestles with human error. We know humans have error rates – we’re not perfect. But how many is too many?