FDA Pharmaceutical and Medical Device Books
Published: September 2010 | Pages: 125 | Price: $377 | ISBN: 978-1-60004-123-5
Clinical trial sponsors always wrestle with the same big challenge — how to maintain the quality and integrity of their clinical trials while pushing their products through the regulatory approvals process. But all too often, trials are delayed by costly errors that can be avoided. Here’s how top-performing sites avoid these pitfalls.
Published: August 2010 | Pages: 131 | Price: $377 | ISBN: 978-1-60004-198-3
Attention drug and device manufacturers — the new health reform law is about to turn your marketing world upside down. Under new rules, companies like yours must begin collecting data about payments to physicians. And that’s just the tip of the iceberg …
Published: July 2010 | Pages: 37 | Price: $377 | ISBN: 978-1-60004-118-1
Will the electronic Common Technical Document (eCTD) submission you design today see your drug smoothly through its entire life cycle? Chances are it won’t — unless you make the right decisions now about everything from naming rules to authorship controls. Here’s where to start:
Published: July 2010 | Pages: 280 | Price: $377 | ISBN: 978-1-60004-112-9
With Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS, you'll have the tools to create and maintain a CCDS that will withstand regulatory scrutiny, and you’ll avoid the unnecessary extra work that comes from assuming what’s the best way to write them.
Published: July 2010 | Pages: 38 | Price: $377 | ISBN: 978-1-60004-114-3
False data in clinical trials isn’t new. What is new is the aggressive role the FDA expects drug and device companies and CROs to play. Under a proposed rule, the FDA says clinical trial sponsors must be proactive in reporting data that is even possibly false. But while it’s clear that noncompliant sponsors will face harsh prosecution, it’s less clear exactly what to report, how … and when.
Published: June 2010 | Pages: 88 | Price: $377 | ISBN: 978-1-60004-110-5
Since 2009, warning letter citations make clear that it’s no longer enough for you to look back at the data and then react to quality problems. You are now expected to trend your quality data.
Published: March 2010 | Pages: 41 | Price: $377 | ISBN: 978-1-60004-106-8
Responding to FDA 483s spells out best practices for managing the post-inspection process so you don’t get callbacks from the FDA. Think of it as “483s for Dummies” — a plain-English step-by-step guide that goes beyond boilerplate advice and digs into specifics that help you fashion a top-quality response to your next Form 483.
Human Error Reduction: Techniques for Stronger CAPAs, Root Cause Analyses and Manufacturing Quality Improvement
Published: March 2010 | Pages: 33 | Price: $377 | ISBN: 978-1-60004-104-4
If you are involved in the manufacture of drugs or biologics, including contract manufacture — in quality, compliance or regulatory affairs — Human Error Reduction is a must-read report.
Published: March 2010 | Pages: 64 | Price: $377 | ISBN: 978-1-60004-096-2
It’s all in Managing Clinical Investigator Compliance, the soon-to-be-released management report from FDAnews that brings you up to speed on the latest requirements for investigators.
Published: November 2009 | Pages: 27 | Price: $377 | ISBN: 978-1-60004-079-5
Cleaning Validation: Strategies for Compliance goes beyond the regulations and digs into the real-life world of cleaning validation. Tips to create an effective master plan ... appropriate SOPs ... auditing for compliance ... practical solutions to troublesome cleaning validation challenges ... this timely volume help keep the FDA at bay, boost production efficiency, and fatten your bottom line.
Published: October 2009 | Pages: 54 | Price: $397 | ISBN: 978-1-60004-081-8
Batch record review is a necessary but thankless task. Many drug manufacturers fob it off on the least trained, most junior QA/review staffers ... but that’s a mistake. Failure to comply with FDA batch record review processes is among the Top Ten most frequent deficiencies cited during agency inspections of drug and biologics manufacturers.
Published: September 2009 | Pages: 45 | Price: $377 | ISBN: 978-1-60004-077-1
SOPs: A Guide to Writing and Maintaining Standard Operating Procedures is the indispensable guide for anyone involved in producing or maintaining these crucial documents.
Published: September 2009 | Pages: 43 | Price: $377 | ISBN: 978-1-60004-083-2
This all-new guide from FDAnews walks you through the steps of managing supplier audits, from initial contract negotiations ... to risk assessment ... to actual conduct of audits ... to documenting and preparing for FDA inspection.
Published: September 2009 | Pages: 125 | Price: $377 | ISBN: 978-1-60004-085-6
This all-new report from FDAnews walks you through the steps that result in first-class supplier-quality agreements — documents that protect you and your customers from problems.
Published: August 2009 | Pages: 76 | Price: $377 | ISBN: 978-1-60004-075-7
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.