
FDAnews Books Library

Gain Access to All Books and Reports
Our 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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Surviving the New FDA Inspection Plan: A Drugmakers Guide to Working with the Agency
December 9, 2019
Taming the Change Control Beast: Creating and Maintaining Effective Change-Control Forms
December 9, 2019