Analytical Method Validation : QbD
Language: English
Published by Wessex, Inc., 2022
- Hardcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 303.74
Quantity: 2 available
Add to basketItem description from seller
nach der Bestellung gedruckt Neuware - Printed after ordering - This book contains essays on data integrity.Data integrity is the most basic element of work in any scientific discipline.Nothing of lasting value in the hard sciences (physics, chemistry, biology,astronomy, et al.) lacks integrity in the data used to support the premises,the logical arguments proposed, and the conclusions drawn. The point ofvalidation is, after all, to ensure that all results obtained and reported aretrue.The original premise of our book was to merge the global standard forpharmaceutical analytical methods for regulatory applications [ICHQ2(R1)] with contemporary thinking on ensuring data quality bythoroughly understanding a method and its intended application (QbD).During a preproduction meeting, an incisive question led to expanding thescope of the original five chapters: 'Can this be applied to fields other thanpharmaceuticals ' The answer was: Yes.Three chapters were added to explore the applications of Quality by Designtheory to real world problems that are bound not only by regulations, but bybusiness constraints, professional ethics, time, resources, and technology. Theymay serve as case studies for classes of advanced students.The scientific approach is rigorous, drawing on, and integrating, classical wetand modern instrumental analytical chemistry knowledge. The reasoning isdetailed and well-documented. Examples are carefully explained. Two arebased on historical events. The other is a problem that is not yet fully resolveddespite its importance and significant risks to human health globally.The tone throughout is conversational. It is intended to involve students -and any reader who has a vested interest in data integrity, which includes theglobal scientific communities from academia, industry, and government, andproducers and consumers of quantitative measurements and the goods andservices obtained by their use.The objective is to impart an intuitive understanding of method validation:planning, execution, and documentation,with examples of practices andproblems, and with practical strategies for addressing both.A special feature is the inclusion of 'Hints' - brief comments offeringexperience-based advice acquired while developing, validating, reviewing, andauditing analytical methods (and data) in a variety of industriesand countries.…
Seller Inventory # 9798987021200
- Title
- Analytical Method Validation : QbD
- Author
- Lawrence A. Wilson
- Publisher
- Wessex, Inc.
- Publication year
- 2022
- Condition
- Neu
- Binding
- Buch
- Language
- English
- ISBN 13
- 9798987021200
- Item weight
- 821 grams
- Dimensions
- 286x221x16 mm
Analytical Method Validation: QbD is a map for the journey from method
design and development to lab experiments to data analysis and proper
documentation. Practical examples of Validation Protocols and associated
Reports, along with case studies across a range of applications, are
explored.
"Synopsis" may belong to another edition of this title.
About the Author
CAROLYN M. MERKEL is the Founding Partner of Mariner Analytical LLC. She earned her BS in Chemistry from Ramapo College of New Jersey; PhD at Columbia University (Inorganic Chemistry, thesis advisor Dr. Stephen J. Lippard), and an additional MS in Technology Management at New Jersey Institute of Technology. She was a Robert A. Welch Fellow at the University of Texas at Arlington (advisor Dr. Donald R. Martin). In her business career, she focused on beverages, food, and nutritional products. After almost 20 years with global consumer product companies, she formed Mariner Analytical LLC. Mariner Analytical provides full-service technical support to a diverse roster of clients, ranging from start-ups to Fortune 50 companies. She consults domestically and internationally on projects ranging from chemical manufacturing and medical devices to dietary supplements and snack foods. She applies her passion for Quality - developed with rigorous training and excellent mentorship - to practice a multidisciplinary approach to problem-solving.She is a Certified Food Scientist, and a member of Sigma Xi, the American Chemical Society, and the Institute of Food Technologists. She has numerous patents and publications, is an accomplished public speaker, and has received awards for teaching and research as well as community service. She believes passionately in education, with active membership in the Ramapo College Alumni Association, currently serving as President, and is honored to be a member of the Ramapo College Board of Governors.
"About the title" may belong to another edition of this title.
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