FDA Pharmaceutical and Medical Device Books
Published: February 2013 | Pages: 338 | Price: $387 | ISBN: 978-1-60428-096-8
In medical device manufacturing, success means staying abreast of regulatory changes from Argentina to the United Kingdom ... and beyond. Impossible? Not at all.
Published: January 2013 | Price: $397
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.
Published: January 2013 | Pages: 62 | Price: $397 | ISBN: 978-1-60428-094-4
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.
Published: January 2013 | Pages: 627 | Price: $397 | ISBN: 978-1-60428-083-8
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?
Published: December 2012 | Pages: 87 | Price: $377 | ISBN: 978-1-60428-089-0
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 Are they outdated? Are they so long you don’t even know if they’re outdated?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…
Published: December 2012 | Pages: 53 | Price: $377 | ISBN: 978-1-60428-079-1
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.
Published: December 2012 | Pages: 85 | Price: $377 | ISBN: 978-1-60428-077-7
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.
Published: December 2012 | Pages: 101 | Price: $377 | ISBN: 978-1-60428-081-4
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.
Published: November 2012 | Price: $1,997
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.
Published: November 2012 | Pages: 231 | Price: $377 | ISBN: 978-1-60428-075-3
Under the latest PDUFA, the FDA has five new criteria for choosing facilities to inspect – are you more likely to be inspected? Do your plans for dealing with drug shortages satisfy the new PDUFA requirements? How about your supplier quality agreements? Your facility registration? Your fast-track NDA? Your . . .
Published: November 2012 | Pages: 240 | Price: $377 | ISBN: 978-1-60428-073-9
You’ve probably read the headline: Under MDUFA 2012, the FDA’s user fees will more than double. But the law does much more than that. It makes major changes to the way the agency regulates devicemakers – touching on everything from approvals to inspections.
Published: September 2012 | Price: $595
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.
Published: September 2012 | Pages: 102 | Price: $377 | ISBN: 978-1-60428-067-8
Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.
Published: September 2012 | Pages: 76 | Price: $377 | ISBN: 978-1-60428-069-2
This comprehensive, step-by-step guide is written by the foremost authorities in the pharmaceutical manufacturing field. It will walk you through an exhaustive, 45-topic analysis of managing contractors. Plus it’s loaded with tools and samples that will make your contract manufacturing headaches disappear.