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  The QSR Companion

Formal Design Reviews

 

 

Table of Contents

Chapter


Title


Page


1 Introduction 1
2 FDA Quality System Inspection Technique 2
3 Management Control Requirements
    Subpart A - General Provisions
        Authority
        Quality System
4
4
4
4
      Subpart B - Quality System Requirements
        Management Responsibility
            Quality Policy
5
5
5
              Organization
            Management Review
            Quality Planning
6
6
6
              Quality System Procedures
        Quality Audit
        Personnel
7
7
7
4 Management Controls Subsystem Inspection     Pre-Announced Inspections
    Getting Started
8
8
8
      Management Controls Flow Chart 9
      Management Controls Inspection 10
5 Design Control Requirements
    General
    Design and Development Planning
14
14
14
      Design Inputs
    Design Outputs
    Design Review
    Design Verification
    Design Validation
    Design Transfer
15
15
15
15
15
15
      Design Changes
    Design History File
16
16
6 Design Controls Subsystem Inspection     Introduction
    Design Controls Flow Chart
17
17
17
      Design Controls Flow Chart 19
7 Corrective & Preventive Action Requirements 27
8 CAPA Subsystem Inspection
    CAPA Flow Chart
    CAPA Inspection
28
29
30
9 Production & Process Control Requirements 38
10 P & PC Subsystem Inspection
    P&PC Flow Chart
    P&PC Inspection
39
39
42
11 Conclusion 48


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