Author: Andrew LoweryPublisher: U.S. Government Printing Office
ISBN: 9780160358449
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Medical Device Good Manufacturing Practices Manual
Author: Andrew LoweryPublisher: U.S. Government Printing Office
ISBN: 9780160358449
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Device Good Manufacturing Practices
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 360
Book Description
Medical Devices Gmp
Author: Handbook of Medical Device Design
Author: Richard C. FriesPublisher: CRC Press
ISBN: 1000696952
Category : Medical
Languages : en
Pages : 491
Book Description
First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
Medical Devices Good Manufacturing Practice
Author: American Society For Quality Control Biomedical DivisionPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Device Good Manufacturing Practices Manual
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
The GMP Handbook
Author: Brendan CooperPublisher: Createspace Independent Publishing Platform
ISBN: 9781548370251
Category :
Languages : en
Pages : 150
Book Description
CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.
Device Good Manufacturing Practices Manual
Author: Medical Device Packaging Handbook, Revised and Expanded
Author: Max ShermanPublisher: CRC Press
ISBN: 9780849384493
Category : Medical
Languages : en
Pages : 422
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.
Device Good Manufacturing Practices
Author: United States. Bureau of Medical Devices. Division of Compliance ProgramsPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 172
Book Description