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.

At its heart, our industry is about saving and improving lives. That’s what draws people into this business in the first place. But sometimes people need reminding about that. That’s what this classic training DVDs has been doing for years, with powerful stories that remind people exactly how GMP compliance affects real life.

You’ll Soon Feel Better was produced for the Association of British Pharmaceutical Industries (ABPI) in 1987 to highlight what can happen when GMPs are not followed. The program is divided into three stories that viewers will relate to.

To a new employee — and even some veterans — the FDA is a mystery: Part cop, part scientist and part politician. But it’s the most important agency you, as a newcomer to the industry, will ever deal with. Wouldn’t it be a good idea to know how the agency really works?

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.

In more than 10 years running the Clinical Trials Centre at the University of Hong Kong, Johan Karlberg, MD, PhD, BSc, helped manage more than 640 sponsored trials, and he witnessed all the hurdles that can trip up trial sites. More GCP training, he concluded, is not the answer to the problems the sites faced. What they needed was a simple mechanism to bring themselves into compliance with GCP regulations and best practices. And the Clinical Trials Magnifier Clinical Trial Site SOPs were born.

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?

What’s in your SOPs? Are they catch-alls, packed with every detail imaginable — everything from what color ink can be used on which documents to where to find the latest informed consent forms? Are they outdated? Are they so long you don’t even know if they’re outdated? After spending countless hours building out elaborate SOPs, at many sites the result is that no one reads them — or can understand them if they do. The impulse to throw up your hands and walk away from the whole issue is a strong one. But there’s hope…