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Author: Ronald Pilchik
Publisher: CRC Press
ISBN: 1040068766
Category : Medical
Languages : en
Pages : 144
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Book Description
According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc
Author: Ronald Pilchik
Publisher: CRC Press
ISBN: 1040068766
Category : Medical
Languages : en
Pages : 144
Get Book Here
Book Description
According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc
Author: Ronald Pilchik
Publisher: CRC Press
ISBN: 1420014943
Category : Medical
Languages : en
Pages : 158
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Book Description
According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc
Author: Ron Pilchik
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
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Book Description
Author: Ron Pilchik
Publisher:
ISBN: 9781566764698
Category : Medical instruments and apparatus
Languages : en
Pages : 380
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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: British Standards Institute Staff
Publisher:
ISBN: 9780580483127
Category :
Languages : en
Pages : 24
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Book Description
Packaging materials, Packaging, Medical equipment, Medical instruments, Sterilization (hygiene), Sterile equipment, Packages, Wrapping, Seals, Packaging processes, Sealing processes, Quality, Acceptance (approval), Quality assurance systems, Verification, Performance, Performance testing
Author: Max Sherman
Publisher:
ISBN: 9780429074691
Category : Biomedical engineering
Languages : en
Pages :
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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."--Provided by publisher.
Author:
Publisher:
ISBN: 9788325105822
Category :
Languages : en
Pages : 14
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Book Description
Author: Institute of Quality Assurance
Publisher:
ISBN: 9780906810583
Category : Drugs
Languages : en
Pages : 134
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Book Description
Guidelines for packaging engineering professionals.
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
