Bigger, Tougher, Faster: Preparing for the New FDA

Bigger, Tougher, Faster: Preparing for the New FDA
When the inspector comes calling ... will you be ready?

Elsevier Business Intelligence announces the publication
of a new 16-page special Report: Bigger, Tougher, Faster: Preparing for the New FDA - When the inspector comes calling ... will you be ready? Originally published in "The Silver Sheet"

Bigger, Tougher, Faster: Preparing for the New FDA

When Commissioner Margaret Hamburg promised to beef up FDA regulatory authority, she wasn't kidding. New inspectors, tighter manufacturing requirements and faster responses to violations — it's all headed your way, and soon. What will all these freshly-trained inspectors be looking for? How can you prepare for a smooth inspection? And what should you do when the worst happens? This Special Report answers all these questions and more, and gives you peace of mind ahead of any inspection, any time.

This detailed 16-page report is a must-read for every QA/QC professional in the medical device industry, whether you're new to the job or a veteran of a thousand inspections.

Prepared by The Silver Sheet's expert analysts, this special report spotlights the new expectations of FDA, outlines what they're looking for and how they'll find it, and what you must do to prepare and respond to avoid costly delays and even major recalls.

This Special Report examines:

** How the FDA is training its new fleet of inspectors and what they're taught to look for.
** When and how to prepare for an inspection.
** Why top management should be included in your preparations.
** The most common mistakes companies make in preparing for inspections.
** The most important issue that investigators will scrutinize.
** How to prepare your response to the inspection.

"You have to get up to speed, otherwise you're going to be totally shocked at the response you're getting from us."

FDA is locked and loaded with 35 additional inspectors, tough new requirements and demands for faster response and corrections. That means you shouldn't just start preparing for an inspection when you get the notification — you have to start the minute your last inspection is over. From setting post-inspection deadlines for yourself to developing a formal warning letter "close-out" process, this report delivers actionable advice from the FDA, industry experts, and QA consultants.

The secret is in the paperwork

What does FDA want? Reports of Corrections and Removals, MDRs, documentation on how employees are trained in new procedures — it's a bewildering chaos of paper, and FDA expects you to understand all of it before they get there. Find out in this report when FDA wants which paperwork, and what should be included in each report.

But we don't manufacture a product that uses heparin!

Doesn't matter. The recent health scares involving a common ingredient in supplements and other ingestible products has fire up FDA on the subject of your supply chain, too. Chances are there's at least one supply item that's escaped your company's proper scrutiny, so you must read this report to get up to speed on every single raw material and component that crosses your doorstep — including those that are subcontracted out by your supplier.

These are just some of the issues and actionable guidance included in this report. And it could only be delivered by "The Silver Sheet," the industry's premier intelligence resource on medical device quality control. Learn More...