FDA Pharmaceutical and Medical Device Books
Published: February 2009 | Pages: 33 | Price: $347 | ISBN: 978-1-60004-028-3
Now available from FDAnews, From 50 Document Management Systems to Three, this information-packed management report provides a step-by-step look at how Pfizer met hardware, software and change-management challenges to create a global document management system (GDMS). While migration involved multiple divisions and software releases, 10,000 users, 118 countries and 12 million documents, Pfizer’s strategy and implementation offer valuable insights for IT consolidation in companies of every size.
Troubleshooting Your Medical Device Quality Management System: A Compliance Guide for the EU, Japan, Canada and More
Published: September 2008 | Pages: 25 | Price: $377 | ISBN: 978-1-60004-004-7
Troubleshooting Your Medical Device Quality Management System: A Compliance Guide for the EU, Japan, Canada and More is the management report that gives you the framework for reviewing your quality system to ensure conformity with ISO 13485, as well as tips for keeping your staff engaged in compliance. Plus, it includes the most commonly overlooked deficiencies that result in findings of nonconformance.
Published: September 2008 | Pages: 237 | Price: $497 | ISBN: 978-1-60004-006-1
Preparation and Maintenance of the IND Application in eCTD Format. Whether you’re still filing IND submissions in paper, or have filed electronically for a while, you’ll value this just-published book from FDAnews. Author William Sietsema, drawing on his real-world experience with IND submissions — and adding real-world case studies from ZymoGenetics and Epix — offers ready-to-use, expert guidance on the content and structure of all the components of an IND in CTD format with the focus on electronic submissions.
Published: August 2008 | Pages: 29 | Price: $397 | ISBN: 978-1-60004-007-8
Managing Supply Chain Risks: Meeting FDA Expectations is the management report that will help you select, audit and monitor outsourcing partners to ensure quality problems are contained and harmful products don’t reach patients. The FDA already has considerable authority to enforce its quality regulations up and down the supply chain. But in the past, it has lacked the resources. In the last six months, that has started to change with increased funding for inspections. And next year, it's likely to change even more as Congress puts together new laws designed to enhance enforcement activities and reach deeper into the supply chain to ferret out potential problems.
Published: July 2008 | Pages: 197 | Price: $337 | ISBN: 978-1-60004-002-3
Tune Up Your CAPA System: A Practical Guide, the management report that will take you through the latest trends in FDA CAPA enforcement, highlight the deficiencies that inspectors are finding and offer you insight into where you should look to determine the effectiveness of your CAPA systems. This management report includes an expert analysis of real-life warning letters and a step-by-step guide to what the FDA looks for when it inspects your CAPA system. Plus, you’ll get a list of best practices to make sure your system can stand up to the agency’s scrutiny.
Published: July 2008 | Pages: 159 | Price: $347 | ISBN: 978-0-98176-350-7
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.
Published: February 2008 | Pages: 102 | Price: $337 | ISBN: 978-1-60004-180-8
Specifically geared to devicemakers, discover how to comply with off-label promotion requirements in the management report brought to you by FDAnews — Device Off-Label Promotion: Case Studies to Prepare for Increased Enforcement. This comprehensive report delivers timely how-to tips, off-label case studies, best practices and more that lets you access 10 targeted compliance strategies for off-label promotions, Avoid foot-in-mouth marketing comments, and know the three types of off-label communications that aren’t violative and what actions your staff must avoid in these situations.
Published: February 2008 | Pages: 287 | Price: $337 | ISBN: 978-1-60004-182-2
Dietary Supplement cGMPs: Final Rule, the management report from FDAnews quickly zeros in on what the most critical areas of these rules mean to your day-to-day operations — and then delivers expert strategies to help you comply with the latest GMP requirements, specifically tailored to dietary supplement manufacturers, save time with a clear, concise “digest” of the FDA’s 700-page ruling, and know when to use exemptions to the rule and how you can request them.
Published: January 2008 | Pages: 64 | Price: $337 | ISBN: 978-1-60004-184-6
Reportedly Trained or Truly Trained: Developing GMP Training that Works, this unique report from FDAnews details what your training program must include to be effective including two areas that should become your training focus and will yield a return on investment, four root causes of inadequate training, three domains of educational activity, four ways that adult learners effectively perceive information, and the six levels of learning and how to determine which level is appropriate for specific tasks.
Published: December 2007 | Pages: 300 | Price: $592 | ISBN: 1460-8375
From FDAnews (published by Euromed Communications), this loose-leaf manual shows you how to satisfy all European regulations affecting your medical devices. You’ll find clear, practical and up-to-date guidance for every class of medical device and at every stage in the product life cycle, from selecting your conformity assessment route to registering with a competent authority and complying with global harmonization.
Published: December 2007 | Pages: 950 | Price: $337 | ISBN: 978-1-60004-133-4
No more sifting through mountains of data! Gain easy, CD-access to a comprehensive collection of documents that helps you establish and maintain an eCTD protocol, with the eCTD Digital Handbook from FDAnews.
Published: December 2007 | Pages: 139 | Price: $337 | ISBN: 978-1-60004-178-5
From FDAnews — Adverse Event Compliance in Device and Diagnostics Clinical Trials. Find clear, concise guidelines on adverse event reporting — specifically for device and diagnostics trials. Make sense of all the whats, whens and hows surrounding adverse event reporting. Once an adverse event happens, it’s too late: you have just 10 working days to submit to the IRB and 10 days after that to get results to the FDA. Stay in control, even when unanticipated events happen.
Published: December 2007 | Pages: 27 | Price: $337 | ISBN: 978-1-60004-166-2
Managing SAS Validation Processes: Mastering the Five Critical Programming Obstacles, the management report from FDAnews, is one of the most widely used software systems in pharma development environments, so your programming expertise will pay off now — and for years to come.
Published: September 2007 | Pages: 67 | Price: $337 | ISBN: 978-1-60004-164-8
Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings, a management report from FDAnews, maps out every aspect of an import hold, including how to fix problems before they land your shipment in trouble with FDA and customs officials, the best way to train your team to use the right (and avoid the wrong) approaches with FDA personnel and when to activate a rapid-response strategy that gets your imports off hold and into use fast.
Published: September 2007 | Pages: 81 | Price: $337 | ISBN: 978-1-60004-144-0
Treatment INDs: Responding to Risks Created by Expanded Access, the management report from FDAnews gathers detail-driven advice on how to protect yourself from the risks — while maximizing the rewards — created by the FDA’s newly proposed rules on experimental drugs. You’ll also learn how to understand groups and individuals that can gain access to your experimental drug. Don’t wait for a liability lawsuit — or the damaging bad press — that can result from adverse events caused by unapproved drugs. Find out where the FDA is headed now.