Analytical Method Validation: QbD - Hardcover

Wilson, Lawrence A; Merkel, Carolyn M

Hardcover

ISBN 13: 9798987021200

Publisher: Wessex, Inc., 2022

Synopsis

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.

About this title

About the Authors

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.

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.

Edition details

• Publisher: Wessex, Inc.
• Publication date: 2022
• Language: English
• ISBN 13: 9798987021200
• Binding: Hardcover
• Number of pages: 218