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
|
Formal Design Reviews