FDA Pharmaceutical and Medical Device Books
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: 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: 168 | Price: $337 | ISBN: 978-1-60004-154-9
This management report from FDAnews, Secrets of Successful Advisory Committee Meetings, brings you the tips and tactics you need to get positive advisory committee recommendations. As the FDA begins to weed out advisory members with ties to drug and device companies, you can still rely on the step-by-step strategies in Secrets of Successful Advisory Committee Meetings to achieve success with the new, more critical round of FDA panelists.
Published: May 2007 | Pages: 109 | Price: $335 | ISBN: 1-60004-058-6
Discover step-by-step how you can profit from shorter cycle times, greater product availability, higher yields and more when you put PAT tools to work at key phases of your manufacturing process. You'll even jump the learning curve with eight dos and don'ts of a successful PAT program.
Published: March 2007 | Pages: 112 | Price: $395 | ISBN: 1-60004-138-8
Don't miss out! Successfully sidestep the delayed approvals, lost product batches and plummeting profits that can result from change control failures with this comprehensive report. Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers.
Published: December 2006 | Pages: 151 | Price: $377 | ISBN: 1-60004-092-6
This indispensable management report maps out a comprehensive strategy for recall planning. From creating a recall committee to handling communication and policy changes during a recall, you'll be at work with today's best practices for containing damage and keeping your edge.
Published: October 2006 | Pages: 106 | Price: $297 | ISBN: 1-60004-075-6
This management report from FDAnews, shows you how to develop a plan to protect yourself from liability and educate your investigators and staff about the importance of upholding confidentiality agreements. Confidentiality in Clinical Trials: Understand Your Liability is a first-line resource to help you learn what the issues are and what you need to do to keep your data secure and your organization safe from unwanted intrusion.
Published: September 2006 | Pages: 239 | Price: $337 | ISBN: 1-60004-071-3
The most complex corrective and preventive action (CAPA) issues are often found outside the routine channels you may already be using to assess and track CAPAs. Make sure you take all the issues into account based on industry guidances and uncover tough-to-spot problems, before they trigger an FDA warning letter.
Published: May 2006 | Pages: 179 | Price: $297 | ISBN: 1-60004-030-X
This management report presents a "master plan" of clinical trial planning to help you get your drugs to market faster, ensure adherence to federal regulations and good clinical practices and keep budgets under control.