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Implementing Quality

Save time and money on the shortcut to quality assurance and regulatory compliance

Quality, quality control, quality assurance, quality management, qualification, validation.... What do they all mean? What's the difference? The answers are simple and surprising. To become proficient all you have to do is forget 80% of what you learned.

David Paspa

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About

About the Book

A distillation of all the knowledge you need to become an expert in quality and validation complete with a toolset to help you do it.

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Author

About the Author

David Paspa

Engineer, working mainly in the Life Sciences since 1988.

Table of Contents

Preface

Executive Summary
Scope
References

Scientific Thinking

The Scientific Method
Definitions
Avoiding Jargon

Focus

Risk Based Approach to Quality
Pre-existing Systems
Sorting Risk
Product Quality Impact Assessment
Functional Risk Assessment
Supplier Assessment
Iteration

FMECA Risk Assessment Method

FMECA Fields
Risk Control Fields
Risk Appetite
Risk Assessment Policy
Risk Assessment Memory Jogger
Sample Risk Register
Sample Risk Controls
Lifecycle Management
V-Model
PLAN
DO
CHECK
Traceability Reporting
ACT

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