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An intro to the FDA’s new draft guidance for Technical Considerations for Additive Manufactured Devices.

Truer words have never been spoken—I only wish it was me who said them.

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Learn more about what companies implementing eIC should expect following the recent release of the FDA draft guidance.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?

In order to measure your GMP compliance (and the effectiveness of your processes and people), ask yourself these five questions.