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When must a process be validated? That is the first crucial question devicemakers must answer. But with no clear guidance from the CDRH, finding the answer can be difficult.
The new FDAnews Management report — Process Validation: A Guide for Devicemakers provides you with the answers. This report will walk you through each point in the decision-making process, including how to determine if a product can be “fully verified,” and how FDA inspectors define that term.
From there, this report will explore in detail each phase of process validation:
You'll learn the latest process validation strategies, proven statistical methods that meet FDA approval and the best ways to document your work, including:
In it, you'll also find a valuable in-depth overview of all of the currently applicable regulatory guidelines that have an impact on process validation for devices, including those from three key sources: the FDA, the International Organization for Standardization (ISO) and the Global Harmonization Task Force (GHTF).
Process Validation: A Guide for Devicemakers teaches the proper application of the regulatory requirements that lead to successful process validation, and also offers advice on the practical issues confronting validation compliance by using real-life anecdotes and scenarios.
You also get invaluable extras, such as checklists for IQ, OQ and PQ — and hundreds of pages of appendices, including the invaluable Medical Device Quality Systems Manual: A Small Entity Compliance Guide, which is no longer available from the FDA.
But, most importantly, throughout the report, you'll find real-life examples that illustrate relevant concepts … show when processes need to be validated … identify the kinds of evidence you need to collect and maintain to demonstrate proper validation … and actual FDA warning letters to help you learn from others' mistakes.
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