Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing / Wiley Series on Biotechnology (PDF)
(Sprache: Englisch)
Sets forth tested and proven risk management practices in
drug manufacturing
Risk management is essential for safe and efficient
pharmaceutical and biopharmaceutical manufacturing, control, and
distribution. With this book as their guide, readers...
drug manufacturing
Risk management is essential for safe and efficient
pharmaceutical and biopharmaceutical manufacturing, control, and
distribution. With this book as their guide, readers...
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Sets forth tested and proven risk management practices in
drug manufacturing
Risk management is essential for safe and efficient
pharmaceutical and biopharmaceutical manufacturing, control, and
distribution. With this book as their guide, readers involved in
all facets of drug manufacturing have a single, expertly written,
and organized resource to guide them through all facets of risk
management and analysis. It sets forth a solid foundation in risk
management concepts and then explains how these concepts are
applied to drug manufacturing.
Risk Management Applications in Pharmaceutical and
Biopharmaceutical Manufacturing features contributions from
leading international experts in risk management and drug
manufacturing. These contributions reflect the latest research,
practices, and industry standards as well as the authors' firsthand
experience. Readers can turn to the book for:
* Basic foundation of risk management principles, practices, and
applications
* Tested and proven tools and methods for managing risk in
pharmaceutical and biopharmaceutical product manufacturing
processes
* Recent FDA guidelines, EU regulations, and international
standards governing the application of risk management to drug
manufacturing
* Case studies and detailed examples demonstrating the use and
results of applying risk management principles to drug product
manufacturing
* Bibliography and extensive references leading to the literature
and helpful resources in the field
With its unique focus on the application of risk management to
biopharmaceutical and pharmaceutical manufacturing, this book is an
essential resource for pharmaceutical and process engineers as well
as safety and compliance professionals involved in drug
manufacturing.
drug manufacturing
Risk management is essential for safe and efficient
pharmaceutical and biopharmaceutical manufacturing, control, and
distribution. With this book as their guide, readers involved in
all facets of drug manufacturing have a single, expertly written,
and organized resource to guide them through all facets of risk
management and analysis. It sets forth a solid foundation in risk
management concepts and then explains how these concepts are
applied to drug manufacturing.
Risk Management Applications in Pharmaceutical and
Biopharmaceutical Manufacturing features contributions from
leading international experts in risk management and drug
manufacturing. These contributions reflect the latest research,
practices, and industry standards as well as the authors' firsthand
experience. Readers can turn to the book for:
* Basic foundation of risk management principles, practices, and
applications
* Tested and proven tools and methods for managing risk in
pharmaceutical and biopharmaceutical product manufacturing
processes
* Recent FDA guidelines, EU regulations, and international
standards governing the application of risk management to drug
manufacturing
* Case studies and detailed examples demonstrating the use and
results of applying risk management principles to drug product
manufacturing
* Bibliography and extensive references leading to the literature
and helpful resources in the field
With its unique focus on the application of risk management to
biopharmaceutical and pharmaceutical manufacturing, this book is an
essential resource for pharmaceutical and process engineers as well
as safety and compliance professionals involved in drug
manufacturing.
Autoren-Porträt
A. HAMID MOLLAH, PhD, is the Head of Quality Engineeringand Validation at XOMA. He has also held positions at Genentech and
Baxter. He is a RAPS Certified Regulatory Affairs Professional and
ASQ Certified Quality Engineer.
Dr. MIKE LONG, has two decades of experience leading
product, process development, and validation efforts on a wide
range of pharmaceutical, medical device, and combination products.
He is a frequent speaker and writer on topics such as risk
management, quality systems, quality by design, and process
validation.
HAROLD S. BASEMAN, MBA, Principal and Chief Operating
Officer, ValSource LLC, has more than thirty years of experience in
pharmaceutical operations, validation, and regulatory compliance.
He has held positions in executive management and technical
operations at several manufacturing and consulting firms.
Bibliographische Angaben
- 2013, 1. Auflage, 432 Seiten, Englisch
- Herausgegeben: Hamid Mollah, Harold Baseman, Mike Long
- Verlag: John Wiley & Sons
- ISBN-10: 1118514378
- ISBN-13: 9781118514375
- Erscheinungsdatum: 25.01.2013
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
eBook Informationen
- Dateiformat: PDF
- Größe: 2.83 MB
- Mit Kopierschutz
Sprache:
Englisch
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