Скачать или смотреть FDA New Inspection Methods and Alignment

FDA is undergoing one of its greatest re-alignments and inspection method updates in the past 30 years. The new enforcement and organizational alignments officially
went into place on May 15, 2017. The new inspection methods are being rolled out this year.

Simply put, what this means for you is two things:

​The old ways of preparing for an inspection are now officially outdated and outmoded. New investigators arrive with iPads and want to see electronic records.

FDA's risk-based inspection priorities means less inspections - but more rigor and more likelihood of enforcement. In other words, when FDA shows up, it's likely because they've already detected a problem at your site or with your products.

This 1-hour webinar will address:

What FDA new inspection methodologies look like for medical device and pharma firms;

The significance of this to your life sciences company; and

What you need to start doing to prepare.​