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  Formal Design Reviews

Formal Design Reviews

 

 

Table of Contents

Chapter


Title


Page


1 INTRODUCTION 1
2 DEFINITIONS 2
3 IMPORTANCE 3
4 BENIFITS 4
5 REQUIREMENTS
    FDA SQR
    ISO 9001
    Layman's Term's

5
6 PURPOSE 7
7 OBJECTIVES 8
8 DESIGN TEAMS
    COMPETENCE/QUALIFICATIONS
    OBJECTIVITY/INDEPENDENCE
    SENSITIVITY

9
9 FOCUS
    INTERNAL
    EXTERNAL

11
10 ELEMENTS OF DESIGN REVIEW
    EVALUATION
    RESOLUTION
    IMPLEMENTATION

12
11 DESIGN REVIEW MEETING TOPICS 14
12 NUMBER AND TYPES OF REVIEWS
    INTIAL DESIGN REVIEW
    DETAILED DESIGN REVIEW
    FINAL DESIGN REVIEW
    AFTER USE DESIGN REVIEW

16
13 RELATIOSHIP TO VERIFICATION & VALIDATION 20
14 FDA QUALITY SYSTEM INSPECTION TECHNIQUE 21


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