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1 Introduction and Background
Hal Baseman and A. Hamid Mollah
2 Risk Management Tools
Mark Walker and Tom Busmann
3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration
Mike Long
4 Statistical Topics and Analysis In Risk Assessment
Mike Long
5 Quality by Design
Bruce Davis
6 Process Development and Clinical Manufacturing
Karen Ginsbury
7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment
Hal Baseman and Mike Bogan
8 Quality Risk Management in Process Lifecycle Validation
A. Hamid Mollah and Scott Bozzone
9 Aseptic Processing: One
James Agalloco and James Akers
10 Aseptic Processing: Two
Edward C. Tidswell
11 Pharmaceutical Product Manufacturing
Marlene Raschiatore
12 Quality Risk Management in Biopharmaceutical Manufacturing
Ruhi Ahmed and Tom Genova
13 Risk Based Change Control
Bill Harclerode, Bob Moser, Jorge Ferreira, and Christophe Noualhac
Index
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Add Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM f, Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing to the inventory that you are selling on WonderClubX
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Add Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM f, Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing to your collection on WonderClub |