The FDA leaves it to you to determine supplier risk and reliability, via audits that you conduct. But make a wrong call and you could face a Form 483, a warning letter or, even worse, liability lawsuits. So here’s the question of the day: Are you doing your best job on audits? If the answer is no … or even maybe … get timely help from FDAnews.

Behind every successful FDA inspection lies a well-run “war room” — the place where key personnel meet to respond to FDA inspectors’ requests, prepare requested documents, and monitor inspection progress. Because the FDA inspector could knock tomorrow morning, an up-to-date war room is essential. Yet far too many drug- and devicemakers neglect to keep their war rooms up to date. Some haven’t even set up one yet. How long has it been since you checked the status of your war room? If you aren’t sure, check out this timely solution from FDAnews.

Order your Nine-Volume Title 21 CFR Set today! The federal government has just compiled the new Nine-Volume Title 21 CFR Set for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

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Order your individual Title 21 CFRs today! The federal government has just compiled the new Title 21 CFRs for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!

This all-new report from FDAnews will help you perform a comprehensive gap analysis that assures your Site Master File matches your company‘s activities. In addition, readers will review up-to-date explanations and analysis of all the new Site Master File changes, a sample document illustrating what the newly overhauled Appendix 8 (Equipment and Devices for Production and Quality Control) of a Site Master File should look like and much more.

Co-authored by GMP experts with international reputations, Pharma Change Control is the perfect starting point to rein in your pharmaceutical manufacturing processes. Every page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements.

Ever want to take your employees inside an FDA inspection interview to show them exactly what can go wrong — and how to avoid these mistakes? Sitting across the table from any regulatory inspector is one of your employees’ most nerve-wracking challenges, even for experienced employees. Now you can give them the confidence they need with a new eLearning course.

Imagine you could look over the shoulders of your company’s employees. Just as they are about to make a mistake, you whisper the right decision in their ear. The fact is, you can’t be on the manufacturing floor, in the labs or control rooms where people face the decisions that will test their training. But you can give them the reinforcement they need to make the right decisions with this six-lesson eLearning package.

Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus. In addition to warning letters, the agency is filing lawsuits and even seizing product. What’s a supplement manufacturer to do? Get up to speed — fast. Take an FDA crash course. How do inspections work? What does the agency expect in document compliance? Which GMP mistakes are most likely to be targeted? Luckily, help is now at hand.

When the FDA investigator reviews your records, will you be able to demonstrate the integrity and security of all the Excel spreadsheets your organization depends on? Make sure the answer is “yes” — with this definitive work on FDA spreadsheet compliance now updated for 2013 ...

International compliance is no longer simply a matter of playing by the same old rules. There’s been a dramatic increase in foreign inspections. Many countries are collaborating via joint inspections and confidentiality agreements that permit sharing of inspection results. And in many countries, drug safety concerns are prompting new requirements. You learn the new rules of the game, or cede the playing field to competitors. That’s where the FDAnews Guide to International Pharma Regulation: 2013 Edition comes in.