FDA Pharmaceutical and Medical Device Books
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: 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.
Published: August 2012 | Pages: 136 | Price: $750
Only one guide aims specifically to help non-Chinese drug manufacturers get into compliance with China’s GMPs. By special arrangement, that guide is now available to FDAnews clients.
Published: June 2012 | Pages: 74 | Price: $377 | ISBN: 978-1-60428-061-6
The FDA adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board. A pity, then, that most drugmakers didn’t use a lifecycle approach when ICH Q10 made its bow ... and didn’t have a clue as to how to begin. Many still don’t. But worry not — help is at hand.
Published: April 2012 | Pages: 644 | Price: $377 | ISBN: 978-1-60428-031-9
What are the five hottest areas of concern showing up in FDA warning letters? How are the agency’s changing priorities impacting its enforcement trends? And what can you do to avoid common pitfalls cited in the FDA’s most recent Warning Letters? The answers are no mystery. They appear in this standout new management report from FDAnews.
Published: April 2012 | Price: $377
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!
Published: February 2012 | Pages: 214 | Price: $377 | ISBN: 978-1-60428-018-0
Before you begin to modify an existing trial, this new report from FDAnews maps out the specific planning and preparation it takes to win FDA approval for adaptive clinical trials. By combining a concise overview with a detailed analysis of FDA’s preferences, this one report advises you on everything thing from the best trial model to use to the best way to avoid technical problems with final data analysis.
Published: January 2012 | Pages: 62 | Price: $377 | ISBN: 978-1-60004-271-3
What would FDA inspectors say if they walked into your lab today and looked at your training records? Are your SOPs up-to-date and complete? Would your sample-handling procedures and archives win praise from an auditor? If you have any doubts, now is the time to take action with this 10-step approach to ensuring quality in GLP-compliant labs…
Published: January 2012 | Pages: 108 | Price: $377 | ISBN: 978-1-60004-016-6
Are you struggling to cope with negotiating dozens of supplier quality agreements? What topics need to be addressed in every quality agreement? What changes at your suppliers’ operations do you need to know about? Does every supplier even need to have a quality agreement?
Published: January 2012 | Pages: 109 | Price: $377 | ISBN: 978-1-60004-269-0
No question about it: social media presents a host of problems for drug and device companies. Still, for brands that manage their presence successfully, the upside potential is huge. But what’s the secret to keeping control over your brand as people share on social media? What does an FDA-proof social media presence look like? What happens if consumers use YouTube, Twitter or Facebook to report previously unknown adverse events? How do you present balanced promotions and important safety information using social media? Here’s how to develop a social media strategy that keeps you compliant and competitive.