On November 23, 2016, the Food and Drug Administration (FDA) published a revised draft guidance for Submission of Quality Metrics Data. The guidance includes significant changes to the earlier quality metrics draft guidance issued by the agency on July 28, 2015.
While a high percentage of FDA 510(k) submissions are rejected the first time (69%!), yours doesn’t have to be one of them.
Without an outcomes based approach where you are ensuring training effectiveness, your employees’ performance will continue to suffer and so will your quality.
An intro to the FDA’s new draft guidance for Technical Considerations for Additive Manufactured Devices.
This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.
A look at making GMP training more engaging and meaningful — to benefit both the business and its personnel.
Learn more about what companies implementing eIC should expect following the recent release of the FDA draft guidance.
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?