A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry PDF by Nuala Calnan, Martin J. Lipa, Paige E. Kane and Jose C. Menezes

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A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry
Edited by Nuala Calnan, Martin J. Lipa, Paige E. Kane and Jose C. Menezes
A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

Contents

Editors ......................................................................................................................xi
Contributors ...........................................................................................................xv
Introduction ......................................................................................................... xix
Section I Making the Case for Knowledge
Excellence in the Biopharmaceutical Industry
1 Why Knowledge Management Is Good Business ...................................3
P.K. Yegneswaran, Michael P. Thien, and Martin J. Lipa
2 Theory of Knowledge Management ......................................................... 19
Stefanie N. Lindstaedt, Paul Czech, and Angela Fessl
3 Knowledge Management—A Japanese Perspective .............................. 41
Yukio Hiyama
4 Accelerating the Opportunity for the Pharmaceutical Industry
through KM ...................................................................................................47
Lauren Trees and Cindy Hubert
Section II Perspectives on Knowledge
5 Who Moved My Facts?: Patient Autonomy and the Evolution
of Infrastructure Mean Best Available Knowledge Is Not
Where It Used to Be ......................................................................................63
Dave deBronkart
6 Valuing Knowledge at Swissmedic— A Regulatory Agency’s
Perspective .....................................................................................................77
Michael Renaudin and Hansjürg Leuenberger
7 Generating New Knowledge from Data: Protecting the Patient
by Exploring What Is “Known” about Quality Defects and
Product Recalls ..............................................................................................97
Nuala Calnan and Anne Greene
8 A Perspective from NASA: Knowledge Services and
Accelerated Learning in NASA—The REAL Knowledge
Approach...............................................................................................117
Ed Hoffman and Jon Boyle
9 An Academic Perspective: Knowledge Management: The
Orphan Enabler—Enabling ICH Q10 Implementation ...................... 133
Nuala Calnan, Anne Greene, and Paige E. Kane
10 An Academic Perspective: Effective Knowledge Assessment .......... 153
Mohamed A. F. Ragab and Amr Arisha
11 Knowledge Management and the Evolving Regulatory Process ..... 165
Bill Paulson and Paige E. Kane
Section III Practices, Pillars and Enablers:
Foundations for Successful KM
12 The House of Knowledge Excellence— A Framework for Success ..... 181
Paige E. Kane and Martin J. Lipa
13 A Holistic Approach to Knowledge Management: Pfizer
Global Supply ..............................................................................................225
Paige E. Kane and Alton Johnson
14 KM Evolution at Merck & Co., Inc.: Managing Knowledge in
Merck Manufacturing Division .............................................................. 243
Martin J. Lipa and Jodi Schuttig
15 Integrating Knowledge Management with Quality
Management Systems to Manufacture Pharmaceuticals
Consistently and Reliably ......................................................................... 261
Barbara Allen
16 Working with the IS/IT Function to Setup Your Knowledge
Management Project for Success ............................................................. 271
Joseph Horvath
17 Knowledge Management Implementation: A Guide to Driving
Successful Technology Realization ........................................................ 281
Doug Redden, DBA
Section IV Practices and Case Studies in
Enabling Knowledge Flow
18 Let’s Talk about Knowledge Management—Learning from the
Library of Alexandria Disaster ................................................................ 297
Matthew Neal and Sandra Bush
19 Rapid and Robust Product Development Powered by
Knowledge Management Capability ...................................................... 313
Anando Chowdhury
20 Knowledge Management Case Study: Using Near Real-Time
Data Analytics and Performance Metrics to Ensure a Robust
and Resilient Supply Chain ..................................................................... 329
Eda Ross Montgomery, Mani Sundararajan, David Lowndes, and
Gabriele Ricci
21 Knowledge Management Elements in Support of Generation
of Chemistry, Manufacturing, and Controls Regulatory
Documentation ............................................................................................ 341
Beth Junker
22 A People Approach to Managing Knowledge: Why Do You
Come to Work and Who Are You Working For? .................................. 361
Siân Slade and Catherine Shen
23 Developing a Lessons Learned Process—Where Lessons Are
Learned: A Case Study of Pfizer Pharmaceutical Sciences ................ 381
Phil Levett
24 Capturing Critical Process and Product Knowledge:
The Development of a Product History File ......................................... 395
David Reifsnyder, Kate Waters, and Kayhan Guceli
25 Communities of Practice: A Story about the VTN and the
Value of Community ..................................................................................407
Renee Vogt, Joseph Schaller, and Ronan Murphy
26 Identification of Critical Knowledge: Demystifying
Knowledge Mapping ................................................................................. 421
Paige E. Kane with a special contribution from Christopher Smalley
27 The Practical Application of a User-Facing Taxonomy
to Improve Knowledge Sharing and Reuse across the
Biopharmaceutical Product Lifecycle: A Case Study ..........................443
Adam Duckworth, Vincent Capodanno, and Thomas Loughlin
28 Knowledge-Based Product and Process Lifecycle Management
for Legacy Products ....................................................................................465
Marco Strohmeier, Christelle Pradines, Francisca F. Gouveia, and
Jose C. Menezes
Conclusion ........................................................................... 497
Index ...............................................................................................505
 
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