Surviving a Japanese Medical Device Inspection is the one management report that will tell you exactly what to expect when Japanese inspectors arrive, how to prepare and manage the inspection process and ensure that inspectors leave happy and confident in your facility's compliance.

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 instructional guide and DVD creates a powerful, hour-long training event that shows employees the types of questions and tactics they’ll face during inspection, and gives them the confidence to respond correctly. Order Today.

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.

Most companies rely on change control forms to track changes and describe current states of control. Adopting and maintaining change control forms that work can be a quality manager’s greatest challenge. Taming the Change Control Beast: Creating and Maintaining Effective Change Control Forms is the indispensable management report for anyone involved in producing or maintaining these crucial documents.

The FDA’s fast-tracking of two molecularly targeted cancer drugs signals a major shift in medicine — and the cancer therapy marketplace. Today, Pfizer and Roche have an edge with their newly approved drugs. But analysts say the flexibility of smaller companies could ultimately give them the edge in new market niches where therapies no longer focus on where the cancer is located, but the cells’ molecular make up and the patient’s genetic factors. Whether this shift represents a concern or an opportunity depends on how you navigate the next five years. Here’s how to see what’s coming — today.

The all-new edition of this FDAnews bestseller provides an overview of each of the CDER policies that are important to you, as well as the full-text versions of those 150 policies in a fully searchable CD. In total, it contains more than 1,100 pages and 23 sections, covering topics ranging from document development and management through review and more!

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.

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.

Finally, there is one book that provides all the tools you need to prepare for an FDA advisory committee meeting, from detailed timelines and messaging tips to rules for crafting effective slides and handling the toughest questions.

Drug manufacturers: Be careful what you wish for. For years, drugmakers have urged the FDA to revisit 21 CFR Part 11, which governs electronic records. Now the FDA has done so — and the industry faces new compliance burdens.

Dubai ... or Denmark? India ... or Indonesia? Where will your next medical device market be? Choosing a new country or region to move into is a high-stakes decision. The right move could double your profits. The wrong one could put you out of business. You need information — lots and lots of it. And not just any information, but the highest-quality, most reliable information you can find. Look no further.

Dubai ... or Denmark? India ... or Indonesia? Where will your next Rx market be? Choosing a new country or region to move into is a high-stakes decision. The right move could double your profits. The wrong one could put you out of business. You need information — lots and lots of it. And not just any information, but the highest-quality, most reliable information you can find. Look no further.

Order your Three-Volume Clinical Trials Title 21 CFR Sets today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

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.