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.

In medical device manufacturing, success means staying abreast of regulatory changes from Argentina to the United Kingdom ... and beyond. Impossible? Not at all.

In this 3-hour DVD seminar, these two veterans will take you through all the issues you’ll need to consider when you negotiate or review a quality agreement from start to finish.

The challenges of e-consent fall into two categories: technical and regulatory. If done right, adopting e-consent technology will yield tremendous benefits. In this management report, you’ll learn how the technology of e-consent can overcome language and literacy barriers, simplify data gathering and remote monitoring and more.

When FDA inspects a clinical trial site, there’s one catch-all citation the investigators love to find. Is it festering at one of your trial sites, waiting to upend your submissions?

Just because a program or an app is running on an unregulated phone or tablet doesn’t mean that the app itself isn’t a medical device in the FDA's eyes. Like it or not, the FDA has made that clear. What’s not so clear? Where the agency draws the line between unregulated products and those the FDA must approve. Until now.

Buy now to immediately come up to speed on the new requirements of the proposed rule. This new report from FDAnews will take the anxiety out of the looming deadlines.

The European regulatory pathway for biosimilars has been in place for years. But if you think understanding the European model means you understand how biosimilars will be approved in the United States, you are making an expensive mistake. The FDA is crafting its own biosimilars regulations. The agency has made it clear that it intends to borrow from the European model in places, but the details of its own approval process have remained largely undefined – until now.

This six-disc package includes six modules, along with leader discussion guides, that illustrate for employees six of the most common mistakes that lead to ruined batches, recalls, or worse. Each 10- to 12-minute scenario shows how and why human errors occur, and reinforces the proper way to handle each situation.

This timely document takes you step-by-step through the most complex, challenging process validation compliance problems, filling in the gaps left in the available guidance.