The Medical Device Validation Handbook, Third Edition PDF Download
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Author: Shawn Schmitt
Publisher:
ISBN: 9781947493889
Category :
Languages : en
Pages : 0
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Book Description
Author: Shawn Schmitt
Publisher:
ISBN: 9781947493889
Category :
Languages : en
Pages : 0
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Book Description
Author: Robert Packard
Publisher:
ISBN: 9780967311524
Category :
Languages : en
Pages : 258
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Book Description
Reference text on validation processes for manufacturing medical devices.
Author: Vernon M. Geckler
Publisher: Wasatch Consulting Resources LLC
ISBN: 0692835415
Category : Law
Languages : en
Pages : 441
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Book Description
This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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Book Description
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Author: Richard C. Fries
Publisher: CRC Press
ISBN: 9780824703998
Category : Medical
Languages : en
Pages : 798
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Book Description
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
Author: Emmet Tobin, Mr.
Publisher: Createspace Independent Publishing Platform
ISBN: 9781977834010
Category :
Languages : en
Pages : 242
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Book Description
At over 200 pages, this pocket book will bring you up to speed quickly on the requirements of process validation. It is divided into logical chapters that sets out the journey of validation in a clear fashion. Many components of Validation for medical devices are transferable. Understanding the fundamental principles of validation allows the reader to apply them to different products and different manufacturing processes. This book is ideal for professionals new to Process Validation. Although it has a practical approach, it is also suited to the academic. Chapter 1: Validation Planning, Chapter 2: Facilities And Utilities Qualification Chapter 3: Equipment And Software Validation Chapter 4: Process Validation Chapter 5: Packaging Validation Chapter 6: Test Method Validation Chapter 7: Measurement Chapter 8: ISO 13485 Chapter 9: Lean
Author: Wayne A. Taylor
Publisher:
ISBN: 9780963512291
Category :
Languages : en
Pages : 0
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Book Description
Author: Max Sherman
Publisher: CRC Press
ISBN: 9780849384493
Category : Medical
Languages : en
Pages : 422
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Book Description
This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more.
Author: Emmet Tobin
Publisher: Createspace Independent Publishing Platform
ISBN: 9781974211579
Category :
Languages : en
Pages : 62
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Book Description
This concise book fits right in the Engineers pocket. It provides a brief introduction to Test method validation and is a useful resource that defines key terms and concepts. The following points are addressed: Examples of Test Method Validations What is test method validation? Why should TMV be performed? When should methods be validated? Regulatory Overview US Food and Drug Administration W.H.O ISO 13485 Definitions and Key Concepts New Test Methods Changes to Existing Methods Accuracy Precision Ruggedness Representative/Continuous Sampling Range Resolution Probability Of False Alarms P (Fa) Probability Of Misses P (M) Validation Protocols What Can Impact the Accuracy of a Test Method? General MSA requirements Variable MSA Studies Attribute MSA Studies Measurement Capability Index
Author: Anne F. Booth
Publisher: CRC Press
ISBN: 9781566767569
Category : Medical
Languages : en
Pages : 142
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Book Description
Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation program. Sterilization Validation and Routine Operation Handbook: Ethylene Oxide is the best practical guide available for the validation of EtO process. The information provided complies with ANSI/AAMI/ISO 11135: 1994, Medical devices-Validation and routine control of ethylene oxide sterilization which is based on a standard developed by the European Standardization Committee (CEN) entitled EN 550, Sterilization of medical devices- Validation and routine control of ethylene oxide sterilization. The text defines methods to assist you in the interpretation and understanding of the requirements in the standard and offers logical procedures for the validation and routine monitoring of your specific ethylene oxide process.
