Name: Engineer 4.0: The Life Science Handbook for Medical Devices and BioPharmaceuticals (en Inglés)
Price: 131005.00 COP
Availability: InStock
Author: O'Brien, Des
ISBN: 9781795753340

portada Engineer 4.0: The Life Science Handbook for Medical Devices and BioPharmaceuticals (en Inglés)

Formato

Libro Físico

Autor

Des O'Brien

Editorial

Independently Published

Idioma

Inglés

N° páginas

386

Encuadernación

Tapa Blanda

Dimensiones

27.9 x 21.6 x 2.0 cm

Peso

0.89 kg.

ISBN13

9781795753340

Categorías

Bibliografias
Ciencias básicas de la medicina preclínica
Ingeniería: general
Biotecnología

Engineer 4.0: The Life Science Handbook for Medical Devices and BioPharmaceuticals (en Inglés)

Des O'Brien (Autor) · Independently Published · Tapa Blanda

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Reseña del libro "Engineer 4.0: The Life Science Handbook for Medical Devices and BioPharmaceuticals (en Inglés)"

This book is inspired by the move towards Industry 4.0, the Fourth Industrial Revolution representing the technological advances that are transforming the manufacturing industry, in particular the capabilities within Life sciences. While the benefits of big data, automation and machine learning will be self-evident, I believe there is a place for underscoring the important of Good Engineering Practice (GEP), quality and compliance in both medical device engineering and Pharmaceuticals. It is important that advancement are based on sound science with an understanding of historical precedencies and regulatory requirements of medical devices and treatments. As powerful new technologies become more mainstream, above all, engineers and scientists must deliver safe and effective products that meet quality and regulatory expectations. This handbook can serve as a physical asset in an age of cloud -based services and information technology. It is based on over 15 years of experience of working in life science industry. It pulls together current practices, regulatory guidance and industry know-how to provide a concise handbook useful for reference or general guidance purposes.Part 2-GXP & COMPLIANCE-2.1 Good Manufacturing Practices2.2 Data Integrity and Principles of CompliancePart 3-MEDICAL DEVICES-3.1 Device Classification3.2 Design Control3.3 ISO 134853.4 Risk Management 3.5 Test Methods Part 4-PHARMACEUTICALS AND BIOPHARMACEUTICALS-4.1 Facilities 4.2 Utilities4.3 Materials Management4.4 Sterile Manufacturing Operations4.5 Depyrogenation Part 5-VALIDATION- 5.1 Validation Planning 5.2 Equipment & Software Qualification5.3 Process Validation5.4 Packaging Validation 5.5 Cleaning ValidationPart 6-ENGINEER 4.06.1 Medical Devices and Apps 6.2 21 CFR Part 11 -Electronic Records & Signatures6.3 Lean Methodologies6.4 Six Sigma6.5 Polymer Processing6.6 Quality and Engineering Tools