Analytical Method Validation: QbD - Rilegato

Wilson, Lawrence A.; Merkel, Carolyn M.

Rilegato

ISBN 13: 9798987021200

Casa editrice: wessex, inc., 2022

Riassunto

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.

Su questo libro

Informazioni sull'autore

LAWRENCE A. WILSON is a Managing Partner of Mariner Analytical LLC. He received undergraduate degrees in Chemistry (BS) and Psychology (BA) from the State University of New York at Oswego, MS in Medicinal Chemistry from Stevens Institute of Technology (with Dr. Ajay K. Bose and Dr. M.S. Manhas), and MBA in Marketing and Management from Fairleigh Dickinson University (thesis: Mathematical Tools for Decision Quality Enhancement). He studied Applied Chemistry at the University of Texas at Arlington on the D.Sc. track and mentored doctoral candidates in a then-novel, work-study program in his research laboratory. He has worked in diverse industries, including: fine chemical manufacturing, heavy industries [mining, building materials (cement, gypsum, roofing, glass), paper], flavors and fragrances, pharmaceuticals, pesticides, polymers (and more) at the laboratory bench, led global Teams, managed research and manufacturing facilities, contributed to multiple marketing applications for successful drugs, and advised on policy - in particular, organizational redesign to accelerate product development. Over the last two decades, he has consulted domestically and globally - chiefly within the pharmaceutical industry - at research, manufacturing/ packaging, and clinical trial sites, with a consistent focus on ensuring data integrity and data quality.

Dettagli dell'edizione

• Editore: wessex, inc.
• Data di pubblicazione: 2022
• Lingua: Inglese
• ISBN 13: 9798987021200
• Rilegatura: Copertina rigida
• Numero di pagine: 218
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile