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FDAnews Online Books Library

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Our Online Books Library gives you year-round unrestricted access to all our books and reports.

They can be accessed, searched, downloaded and read anywhere, anytime. Topics covered include inspections, auditing, validation, recalls, pharmacovigilance, biosimilars, adverse events, QSR Data, supply chain, financial disclosure requirements and much more. You’ll automatically receive every new book we publish — we'll send you notifications to alert you of each new book in the library.

And as an added bonus you’ll receive the most up-to-date editions of the FDA’s Code of Federal Regulations and its Investigations Operations Manual.

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Writing SOPs: Best Practices for Life Sciences Companies

December 9, 2019

Your standard operating procedures are one of the first things FDA investigators will look at during an inspection. Yet, "inadequate SOPs" rank among the most-frequently cited Form 483 observations. This new management report will teach you the practical techniques you need for crafting well-written, fast-read, flexible and compliant SOPs - SOPs that will meet FDA requirements as well as today's globalized expectations.

Use QSIT to Your Advantage in FDA Device Inspections

December 9, 2019

This management report offers you a one-two punch of value and knowledge, relying on the combined expertise of Tim Wells, the man who literally wrote the book on QSIT inspections, and Jodi Scott of the law firm Hogan Lovells, an expert in QSR, adverse event reporting and field action requirements. With this report you'll find out how the FDA determines your risk profile, and learn important red flags that can alert you that an inspector is sniffing around for a specific problem.

Using ISO 11607 to Develop Risk-Based Device Packaging

December 9, 2019

Using case studies and other frontline knowledge this report will show you how to leverage a risk-based packaging approach to prevent nasty audits and recalls ... without busting a hole in your compliance budget. With it, you'll get step-by-step guidance through the bewildering FDA packaging requirements, beginning with a discussion of how and why packaging is causing significant harm to devicemakers. You'll also learn why your packaging might be at risk - and what you must do to reduce field complaints, recalls or FDA enforcement actions.

Using Social Media in Clinical Trial Recruitment

December 9, 2019

Today, one in five sponsors uses social media to engage, recruit, and retain subjects for clinical trials. And why not? Clearly, social media is increasingly where your prospective study subjects are going to be found. This report is designed to help unsure clinical trial recruiters put aside their concerns and go ahead with social media recruiting of trial subjects. And if you're already using social media, it's an opportunity to hear how other organizations are overcoming challenges and employing social media for increasingly successful recruitment.

Using the MDSAP Model to Win International Device Approval

December 9, 2019

This management report explains what MDSAP auditors will focus on and teaches you how to build an internal audit program that will get your quality system in state-of-the-art shape for international inspections.

Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports

December 9, 2019

If you want to market your device in Europe, you need to provide clinical evidence that the product is safe and effective. But if your development phase didnt include clinical trials, how can you make that argument? This FDAnews Brief walks you through the process of developing and writing a CER with a 7-point model that ensures you cover all the bases and have the greatest chance of success.

Understanding the New EU Medical Device Regulations

December 9, 2019

The EU has just made sweeping changes to its medical device regulations (MDR) replacing the three current guidance directives with two massive regulations binding manufacturers to a variety of new requirements. This management report directs you through the new MDR and in vitro diagnostic device regulations (IVDR) and explains the impact on the development, marketing and monitoring of your devices.

Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC

December 9, 2019

Drug and device advertising, marketing and promotion are edging into some brave new worlds. Its not OK for creative teams to operate unaware of FDA and FTC rules and attitudes. This report takes a deep dive into six areas regulators give the most attention.

Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps

December 9, 2019

Medical device manufacturers often dread the FDA inspector's arrival. But here's a shortcut to success you can master in an hour or so. There is a little-known secret: Five problem areas account for one-fourth of all Form 483 observations the FDA issues devicemakers in a given year. Master these and you've taken a giant step toward inspection success. And now, FDAnews has created a management report focusing on just those five areas.

UDI Direct Marking for FDA Compliance: Navigating New Rules

December 9, 2019

Confused by the FDAs UDI direct marking regulations? What information should go on the label and the device itself? What methods of marking are acceptable? Jay Crowley, the go-to expert on UDI compliance and the architect of UDI while at the FDA, lays out a path to compliance in this FDAnewsBrief.

The Revised Common Rule: New Requirements for Clinical Trials

December 9, 2019

Two prominent healthcare attorneys sift through the new rule to mark out every deletion highlight every addition interpret every rewording that clinical research professionals and institutions will need to understand to be compliant.

Tools for Faster Drug and Device Development: FDA's New Pathways to Innovation

December 9, 2019

This comprehensive collection of FDA guidances and policies on drug and device development tools features a preface by noted FDA law expert Jim O'Reilly laying out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it.