Validation for Medical Device and Diagnostic Manufacturers, Second Edition,9781574910636

Validation for Medical Device and Diagnostic Manufacturers, Second Edition

by ;
Edition: 2nd
ISBN13: 9781574910636
ISBN10: 1574910639
Format: Hardcover
Pub. Date: 1997-09-30
Publisher(s): CRC Press
  • Free Shipping Icon

    This Item Qualifies for Free Shipping!*

    *Excludes marketplace orders.

List Price: $241.50

Buy New

Arriving Soon. Will ship when available.
$230.00
Add to Cart

Rent Textbook

Select for Price
Add to Cart
There was a problem. Please try again later.

Rent Digital

Rent Digital Options
Online:180 Days access
Downloadable:180 Days
$191.40
Online:365 Days access
Downloadable:365 Days
$226.20
Online:1825 Days access
Downloadable:Lifetime Access
$348.00
$191.40
Add to Cart

Used Textbook

We're Sorry
Sold Out

Buy from our Marketplace starting at $177.91

How Marketplace Works:

  • This item is offered by an independent seller and not shipped from our warehouse
  • Item details like edition and cover design may differ from our description; see seller's comments before ordering.
  • Sellers much confirm and ship within two business days; otherwise, the order will be cancelled and refunded.
  • Marketplace purchases cannot be returned to eCampus.com. Contact the seller directly for inquiries; if no response within two days, contact customer service.
  • Additional shipping costs apply to Marketplace purchases. Review shipping costs at checkout.

Summary

Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.

Table of Contents

Introduction xiii
Introduction to Quality Systems
1(6)
Quality Control, Quality Assurance, and Quality Systems
2(1)
Quality System Summary
3(1)
Quality System Requirements in Five Steps
4(1)
The Commitment to Validate
4(1)
Bibliography
5(2)
Validation Overview
7(14)
Regulations, Guidelines, and Expectations for Validation Studies
7(2)
When Are Validation Studies Required? When Are Validation Studies Appropriate?
9(1)
When Are Validation Studies Performed in the Product Life Cycle?
10(1)
Design, Process, and Method Validation Relationships
10(1)
Who Designs and Performs Validation Studies?
11(1)
When Clinical Use Product Is Produced in the Development Laboratory
12(1)
Specification Testing
12(1)
Validation Studies Versus Qualification Studies
13(1)
Validation Study Strategies
14(1)
Fundamental Elements of Validation
14(1)
Validation Terminology and Definitions
15(1)
Prospective and Retrospective Validation Studies
15(2)
Revalidation
17(1)
Summary
18(1)
A Look Ahead
18(1)
References
18(1)
Bibliography
19(2)
Product Development and Validation
21(20)
Design Input: Defining the Product Design Endpoint
21(2)
Designing and Design Analysis
23(1)
Design Output: Documenting the Design
23(1)
Design Verification: Demonstrating That the Design Endpoint Is Achievable
24(2)
Design Validation: Demonstrating That User Requirements Are Satisfied
26(3)
Medical Device Software Validation
29(1)
Ensure That Design Verification and Validation Studies Are Meaningful
30(1)
Design Validation and Design Transfer
31(1)
The Evolution of Validation for Medical Product Manufacturers
32(2)
References
34(2)
Appendix 3.A. Content Considerations for a Design Verification Study Plan and Protocol
36(1)
Appendix 3.B. Content Considerations for a Design Validation Study Plan and Protocol
37(2)
Appendix 3.C. Design Transfer Decision Record
39(2)
Validation Study Plans, Protocols, Reports
41(8)
Validation Study Master Plans
42(1)
Validation Study Plans or Protocols
42(2)
Validation Study Reports
44(1)
Validation Study Notebooks/Validation Study Files
44(1)
Validation Study Disposition Records
44(1)
References
45(1)
Appendix 4.A. Format and Content Considerations for a Validation Study Master Plan
46(3)
Process Development and Validation
49(18)
Process Development
50(5)
Process Validation Studies
55(1)
Process Validation Candidates
56(1)
Validation Studies Can Minimize Process Specification Testing
57(1)
Are Validation Studies the Only Option?
58(1)
Who Performs Validation Studies and When?
59(1)
Process Validation or Qualification Study Protocols: Format and Content Considerations
59(3)
Equipment-Dependent Processes
62(1)
Process Failures and Out-of-Specification Results
62(1)
Revalidation
62(1)
Summary
63(1)
Bibliography
63(1)
Appendix 5.A. Sample Process Validation Study Protocol
64(3)
Test Method Development and Validation
67(18)
Test/Inspection Method Validation: Regulatory Requirement or NOT?
68(1)
The Life Cycle of a Test/Inspection Method
69(1)
Method Development
70(4)
Method Control: Is Validation the Only Option?
74(2)
Who Performs the Study?
76(1)
Method Qualification or Validation
76(1)
Study Protocol Format and Content: Test/Inspection Methods
77(2)
Routine Monitoring of a Validated Test/Inspection Method
79(1)
Method Failures Versus Out-of-Specification Results
80(1)
Training of Technicians
80(1)
In Vitro Diagnostics: When the Test Method Is the Product
81(1)
Summary
82(1)
References
82(1)
Bibliography
83(2)
Qualification of Equipment and Equipment Systems
85(24)
What About Equipment Validation?
85(1)
What Equipment Requires a Qualification Study?
86(1)
Equipment Qualification Study Protocol: Format and Content
87(3)
Equipment and Equipment System Development During Start-Up
90(1)
Use of Contract ``Validation'' Services
91(1)
New or Existing?
91(1)
Equipment Versus Equipment Systems
92(1)
The Commitments of Routine Maintenance, Calibration, and Change Control
93(1)
Bibliography
93(2)
Appendix 7.A. Sample Installation Qualification for a Clean Steam Aenerator
95(5)
Appendix 7.B. Sample Equipment Qualification Study Protocol for a Hot Air Curing Oven
100(4)
Appendix 7.C. Sample Validation Protocol for a Compressed Air Production and Distribution System
104(5)
Qualification of Software-Driven, Automated Equipment and Equipment Systems
109(18)
Software-Driven, Automated Equipment Systems
110(2)
Software Installation Qualification Records
112(1)
Software Operational Qualification Study Protocols
112(1)
Software Performance Studies
113(1)
Where to Start?
114(1)
Categorization of Concern
114(1)
Software Requirements
115(1)
Qualification Data Options for Automated Systems
116(1)
Simple Equipment Systems Should Require Simple Evaluation
117(1)
Supporting Qualified, Software-Driven, Automated Equipment Systems
117(1)
References
118(1)
Bibliography
118(4)
Appendix 8.A. Points to Consider: Software Identification and Control
122(1)
Appendix 8.B. Points to Consider: Hardware and Equipment Configuration Management
123(2)
Appendix 8.C. Points to Consider: Good Automated Manufacturing Practices
125(2)
Facility Qualification Studies
127(14)
Facility Intended Use or Purpose
127(3)
Facility Requirements and Specifications
130(2)
New Facility Construction and Renovation
132(1)
Facility Qualification Study: Overview
133(1)
Format and Content of a Facility Qualification Study Protocol
134(5)
Existing Facility Qualification Studies
139(1)
Changes in a Qualified Facility
140(1)
Validation Studies at Suppliers or Contractors
141(12)
Who Is Responsible?
142(1)
Validation Studies at Suppliers
142(1)
Managing the Contracts
143(1)
Changing Suppliers
144(1)
References
145(1)
Bibliography
146(1)
Appendix 10.A. Points to Consider in Contract Relationships
147(6)
Change Management for Validated Products, Processes, and Methods
153(10)
Change Detection Programs
154(1)
Unexpected Change from Suppliers
155(1)
Unexpected Results from Validated Products, Processes, or Methods
156(1)
Proposed Changes to Validated Product, Processes, or Methods
157(1)
When Preapproval from the FDA Is Required
157(2)
Unexpected Results During a Validation Study
159(1)
Revalidation Study Protocols
160(1)
References
160(1)
Bibliography
160(3)
Revalidation and Requalification Studies
163(142)
Revalidation Studies
164(1)
Time-Based Requalification/Revalidation Studies
165(1)
How Much Testing Is Enough?
166(1)
Revalidation Study Protocol
167(1)
Revalidation/Requalification Study Protocol: Documentation Requirements
168(1)
Reference
168(1)
Appendices
A. 21 CFR Part 820-Quality System Regulation
169(22)
B. Current Good Manufacturing Practice (cGMP) Final Rule: Quality System Regulation
191(24)
Deign Controls
Production and Process Controls
C. Medical Device Quality Systems Manual: A Small Entity Compliance Guide
215(52)
Design Controls
Process validation
Equipment and Calibration
D. General Principles of Software Validation
267(28)
E. Proposed Amendment of Certain Requirements for Finished Pharmaceuticals
295(10)
Process Validation
Method Validation
Index 305

An electronic version of this book is available through VitalSource.

This book is viewable on PC, Mac, iPhone, iPad, iPod Touch, and most smartphones.

By purchasing, you will be able to view this book online, as well as download it, for the chosen number of days.

Digital License

You are licensing a digital product for a set duration. Durations are set forth in the product description, with "Lifetime" typically meaning five (5) years of online access and permanent download to a supported device. All licenses are non-transferable.

More details can be found here.

A downloadable version of this book is available through the eCampus Reader or compatible Adobe readers.

Applications are available on iOS, Android, PC, Mac, and Windows Mobile platforms.

Please view the compatibility matrix prior to purchase.