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Title:

Risk management applications in pharmaceutical and biopharmaceutical manufacturing / edited by A. Hamid Mollah, Mike Long, Harold S. Baseman.

Publisher:

Wiley,

Copyright Date:

2013

Description:

xvii, 393 pages, 12 unnumbered pages of plates : illustrations (some color) ; 24 cm.

Subject:

Pharmaceutical biotechnology.
Pharmaceutical biotechnology industry--Risk management.
Pharmaceutical technology.
Pharmaceutical industry--Risk management.

Other Authors:

Mollah, A. Hamid, 1962-
Long, Mike, 1968-
Baseman, Harold, 1956-

Notes:

Includes bibliographical references and index.

Contents:

Machine generated contents note: 1.Background and Introduction / A. Hamid Mollah -- 2.Risk Management Tools / Thomas 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 S. Davis -- 6.Process Development and Clinical Product Manufacturing / Karen S. Ginsbury -- 7.Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment / Michael Bogan -- 8.Process Lifecycle Validation / Scott Bozzone -- 9.Aseptic Processing: One / James E. Akers -- 10.Aseptic Processing: Two / Edward C. Tidswell -- 11.Pharmaceutical Product Manufacturing / Marlene Raschiatore -- 12.Biopharmaceutical Manufacturing / Thomas Genova -- 13.Risk-Based Change Control / Christophe Noualhac.

Series:

Wiley series in biotechnology and bioengineering

ISBN:

0470552344 (cloth)
9780470552346 (cloth)

OCLC:

(OCoLC)726822927

LCCN:

2012045117

Locations:

OVUX522 -- University of Iowa Libraries (Iowa City)