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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:
Planning and protocol design;
Data collection;
Data analysis; and
Reporting and recordkeeping.
You'll learn the latest process validation strategies, proven statistical methods that meet FDA approval and the best ways to document your work, including:
The concepts of process validation — including the distinction between product verification and process validation
When and how to validate a process
The requirements in the QSR and how to understand them
The relationship between the QSR and ISO 13485:2003
What to expect during an FDA inspection
How to use QSIT in process validation, including sampling plans
The issues raised by recent warning letters and how they can help guide your approach
The role of installation qualification (IQ) and the relationship with OSHA regulations
How to set a maintenance schedule and use Total Productive Maintenance
How to use statistical tools, including the process model, capability and performance indices and attribute acceptance sampling
How to use operational qualification (OQ), including design transfer and challenge tests
The role of performance qualification (PQ), including process monitoring and revalidation
Production issues for validated processes, such as hazard analysis and critical control points and risk management
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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PDF Edition — $397
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PDF Edition — $397
Table of Contents
Introduction
Key Concepts: Regulatory Framework for Process Validation
Project managers involved in design and development
Design engineers
Quality engineers
Manufacturing engineers
Quality auditors
Production managers
Production supervisors
Scientists involved in device research and development
Medical staff evaluating risk, safety or effectiveness
Quality or regulatory staff assigned to complaint, CAPA, or MDR management
Training personnel
General/corporate counsel
Production engineers
Risk management specialists
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