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02568aam a2200385 i 4500 001 04546606E2DD11E284C630D7DAD10320 003 SILO 005 20130702010114 008 130214t20132013njua b 001 0 eng 010 $a 2012045117 020 $a 0470552344 (cloth) 020 $a 9780470552346 (cloth) 035 $a (OCoLC)726822927 040 $a DLC $b eng $e rda $c DLC $d YDX $d BTCTA $d YDXCP $d BDX $d OCLCO $d CDX $d AU@ $d SILO 042 $a pcc 050 00 $a RS380 $b .R57 2013 082 00 $a 338.4/76151 $2 23 245 00 $a Risk management applications in pharmaceutical and biopharmaceutical manufacturing / $c edited by A. Hamid Mollah, Mike Long, Harold S. Baseman. 264 1 $a Hoboken, New Jersey : $b Wiley, $c [2013] 300 $a xvii, 393 pages, 12 unnumbered pages of plates : $b illustrations (some color) ; $c 24 cm. 490 1 $a Wiley series in biotechnology and bioengineering 504 $a Includes bibliographical references and index. 505 0 $a 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. 650 0 $a Pharmaceutical biotechnology. 650 0 $a Pharmaceutical biotechnology industry $x Risk management. 650 0 $a Pharmaceutical technology. 650 0 $a Pharmaceutical industry $x Risk management. 700 1 $a Mollah, A. Hamid, $d 1962- 700 1 $a Long, Mike, $d 1968- 700 1 $a Baseman, Harold, $d 1956- 776 08 $i Online version: $t Risk management applications in pharmaceutical and biopharmaceutical products manufacturing $d Hoboken, New Jersey : John Wiley & Sons, Inc., [2013] $z 9781118526187 $w (DLC) 2013007232 830 0 $a Wiley series in biotechnology and bioengineering. 941 $a 1 952 $l OVUX522 $d 20191213022629.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=04546606E2DD11E284C630D7DAD10320Initiate Another SILO Locator Search