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FDAnews Books Library

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Implementing Risk-Based Verification and Validation

December 9, 2019

Switching to risk-based verification and validation is likely to save you money on projects, plus reduce liability and recalls. Itwhat'ss a good business idea. And what's more, the FDA is pushing you to do it. But like any basic change, there's a learning curve. Are you ready? This all-new management report from FDAnews is just the ticket for drug and device manufacturers ready to take the first step ... and seeking a helping hand. Your guide, consultant John E. Lincoln, has more than 30 years of experience assisting drug and device manufacturers to design new products, pilot them, set up production, validate and bring them to market.

Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices

December 9, 2019

IVDs, LDTs, RUOs, IUOs, ASRs, and GPRs — regulation of in vitro diagnostic devices is an alphabet soup of confusion. This report brings together all the disparate parts of IVD regulations and guidances and provides an expert interpretation of requirements.

FDAnews Guide to International Pharma Regulation: 2015 Edition

December 9, 2019

Learn about the regulatory developments affecting drug production in more than 22 nations around the world. Our editorial staff has compiled more than 150 reports highlighting changes from the past year, cover key issues such as emerging changes in inspection practices, changes to quality manufacturing requirements, new biosimilars legislation and regulation, changing product registration requirements, evolving patent laws and more.

Drafting Clinical Trial Agreements: Using the Right Words and Phrases

December 9, 2019

This new report from FDAnews and CenterWatch gives you a crash course in what you should and shouldnt say in a CTA. It defines words and phrases in a legal context and explains whats binding and whats not.

Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers

December 9, 2019

Ten of the industrys top medical device experts, who have together managed thousands of root cause investigations and successfully opened and closed more CAPAs than they can remember, share everything from the nuts and bolts of CAPA management to the most innovative best practices.

Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends

December 9, 2019

Its certain that your complaint management system will come under intense scrutiny in your next GMP inspection. This report teaches the principles of effective systems as well as how to analyze trends in complaint files to spot opportunities for product and program improvement.

ClinicalTrials.gov: Mastering the New Reporting Rules

December 9, 2019

This report parses out the 42 CFR Part 11, Final Rule for Clinical Trials Registration and Results Information provisions, explaining who must report what, what information you must submit, what the deadlines are and what could happen if you miss the mark.

Best Practices for Adaptive Clinical Trials: FDA Guidance and Philosophy

December 9, 2019

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 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.

A Process Approach to Pharmaceutical Quality Systems: A Guide to ICH Q10 Compliance

December 9, 2019

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. This all-new management report helps you bring your drug manufacturing quality systems into compliance.