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[资源] Risk Management Applications in Pharmaceutical and Biopharmaceutical

1 Background and Introduction 1
Harold S. Baseman and A. Hamid Mollah
2 Risk Management Tools 17
Mark Walker and Thomas Busmann
3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration 49
Mike Long
4 Statistical Topics and Analysis in Risk Assessment 75
Mike Long
5 Quality by Design 89
Bruce S. Davis
6 Process Development and Clinical Product Manufacturing 101
Karen S. Ginsbury
7 Points to Consider for Commissioning and Qualiﬁcation of Manufacturing Facilities and Equipment 129
Harold S. Baseman and Michael Bogan
8 Process Lifecycle Validation 179
A. Hamid Mollah and Scott Bozzone
9 Aseptic Processing: One 227
James P. Agalloco and James E. Akers
10 Aseptic Processing: Two 243
Edward C. Tidswell
11 Pharmaceutical Product Manufacturing 275
Marlene Raschiatore
12 Biopharmaceutical Manufacturing 325
Ruhi Ahmed and Thomas Genova
13 Risk-Based Change Control 367
William Harclerode, Bob Moser, Jorge A. Ferreira, and Christophe Noualhac

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附件 1 : Risk_Management_Applications_in_Pharmaceutical_and_Biopharmaceutical_Manufacturing.pdf

2015-05-22 20:50:36, 2.37 M