A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry (Biotechnology and Bioprocessing) (Paperback)

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry (Biotechnology and Bioprocessing) Cover Image
By Nuala Calnan (Editor), Martin J. Lipa (Editor), Paige E. Kane (Editor)
$81.84
WE CAN ORDER THIS FOR YOU (store pickup in 5-14 days)
(This book cannot be returned.)

Description


This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation's knowledge assets can provide a path towards business excellence.

About the Author


Nuala Calnan, PhD has over 20 years' experience in the pharmaceutical industry and is currently an adjunct Research Fellow with the Pharmaceutical Regulatory Science Team at DIT, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level.Dr. Calnan's focus is on the integration of Knowledge Excellence, Operational Excellence, & Cultural Excellence in delivering enhanced quality outcomes for the patient and has led a recent Irish Industry research study in this field examining the Product Recall and Quality Defect data at the Irish medicines regulator, HPRA. She is currently a member of the St. Gallen University led team who were awarded a one-year research grant by FDA examining the role of Quality Metrics in determining risk-based inspection planning. Dr. Calnan also works closely with industry in the areas of Quality Excellence and Metrics, Data Integrity and Quality Culture development.Dr. Calnan co-leads the ISPE Quality Culture Team and the ISPE/ PQLI Task Team on Knowledge Management.Martin Lipa is an Executive Director in Merck Manufacturing (MMD) and leader of the MMD Knowledge Management Center of Excellence (Knowledge Management CoE). For the past 8 years he has worked to create Knowledge Management strategy for Merck Manufacturing and other functions across the Merck enterprise and to build capabilities and competency in Knowledge Management as an enabler of the company's strategy. Lipa has over 20 years' experience in the biopharmaceutical industry. Prior to focusing on Knowledge Management, he started his career as a Technical Operations engineer and then progressed through roles in shop floor automation, computer systems validation, new GxP facility startup, project management and clinical supplies. He is also a certified LSS Black Belt and specializes in change management techniques.


Product Details
ISBN: 9780367875725
ISBN-10: 0367875721
Publisher: CRC Press
Publication Date: December 12th, 2019
Pages: 548
Language: English
Series: Biotechnology and Bioprocessing