Author: United States. General Accounting OfficePublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 104
Book Description
Medical Technology
Author: United States. General Accounting OfficePublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 104
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
Author: United States. Bureau of Medical Devices. Division of Compliance ProgramsPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 172
Book Description
Everything You Always Wanted to Know about the Medical Device Amendments
Author: United States. Bureau of Medical DevicesPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 68
Book Description
Technological Innovation
Author: Annetine C. GelijnsPublisher: National Academies
ISBN:
Category : Clinical medicine
Languages : en
Pages : 78
Book Description
Medical Devices Gmp
Author: Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Reliable Design of Medical Devices
Author: Richard C. FriesPublisher: CRC Press
ISBN: 1420027948
Category : Medical
Languages : en
Pages : 490
Book Description
As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.
Combination Products
Author: Smita GopalaswamyPublisher: CRC Press
ISBN: 1040068960
Category : Business & Economics
Languages : en
Pages : 168
Book Description
The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing
Medical Product Regulatory Affairs
Author: John J. TobinPublisher: John Wiley & Sons
ISBN: 3527644717
Category : Science
Languages : en
Pages : 304
Book Description
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.