LEADER 03068nam 22005774a 450 001 9910830871703321 005 20230828201103.0 010 $a1-280-44808-3 010 $a9786610448081 010 $a0-470-23938-7 010 $a0-471-78478-8 010 $a0-471-78477-X 035 $a(CKB)1000000000355049 035 $a(EBL)257215 035 $a(OCoLC)162401253 035 $a(SSID)ssj0000149621 035 $a(PQKBManifestationID)11150502 035 $a(PQKBTitleCode)TC0000149621 035 $a(PQKBWorkID)10239121 035 $a(PQKB)10043307 035 $a(MiAaPQ)EBC257215 035 $a(EXLCZ)991000000000355049 100 $a20050819d2006 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aEstablishing a CGMP laboratory audit system$b[electronic resource] $ea practical guide /$fDavid M. Bliesner 210 $aHoboken, N.J. $cWiley-Interscience$dc2006 215 $a1 online resource (295 p.) 300 $aDescription based upon print version of record. 311 $a0-471-73840-9 320 $aIncludes bibliographical references and index. 327 $aPreface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 "Drug manufacturing inspections" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations. 330 $aThe first systematic, hands-on auditing guide for today's pharmaceutical laboratoriesIn today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely 606 $aPharmaceutical industry$zUnited States 606 $aDrugs$xLaw and legislation$zUnited States 610 $aCurrent Good Manufacturing Practices 615 0$aPharmaceutical industry 615 0$aDrugs$xLaw and legislation 676 $a343.7307/86151 676 $a542.1 700 $aBliesner$b David M$0890967 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830871703321 996 $aEstablishing a CGMP laboratory audit system$94063827 997 $aUNINA LEADER 03722nam 22006615 450 001 9910338034703321 005 20240312114041.0 010 $a9783319923512 010 $a331992351X 024 7 $a10.1007/978-3-319-92351-2 035 $a(CKB)4100000007003165 035 $a(MiAaPQ)EBC5555652 035 $a(DE-He213)978-3-319-92351-2 035 $a(PPN)259455199 035 $a(Perlego)3491333 035 $a(EXLCZ)994100000007003165 100 $a20181014d2019 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aGovernment-Business Relations and Regional Development in Post-Reform Mexico /$fby Theodore Kahn 205 $a1st ed. 2019. 210 1$aCham :$cSpringer International Publishing :$cImprint: Palgrave Macmillan,$d2019. 215 $a1 online resource (xv, 290 pages) $cillustrations 225 1 $aLatin American Political Economy,$x2945-7084 311 08$a9783319923505 311 08$a3319923501 327 $a1. Introduction -- 2. Governing Subnational Economies -- 3. Origins and Consequences of Divergent Private Sector Organization in Puebla and Querétaro -- 4. Building Institutions for Cooperation in Querétaro, 1979-1991 -- 5. Partisan Rivalry between Government and Business in Puebla, 1981-1993 -- 6. Consolidation of a Developmental Alliance in Querétaro, 1991-1997 -- 7. Authoritarian Political Economy and Global Integration in Puebla, 1993-1999 -- 8. Querétaro's Rising Star in the Global Economy, 1997-2009 -- 9. Institutional Erosion and Economic Stagnation in Puebla, 1999-2011 -- 10. Conclusion. 330 $aThis book explores the political economy of subnational development in Mexico. Like much of Latin America, Mexico underwent market reforms and democratization in the late 20th century. In addition to transforming national institutions, these changes led to sharp political and economic divergence among Mexican states. The author offers a novel explanation for these uneven results, showing how relations between local governments and organized business gave rise to distinct subnational institutions for managing the economy. The argument is developed through a paired comparison of two states in central Mexico, Puebla, and Querétaro. This work will be of interest to students of Latin American and Mexican politics, regional development, and government-business relations. Theodore Kahn is Visiting Scholar in the Latin American Studies Program at the Johns Hopkins University School of Advanced International Studies, USA. 410 0$aLatin American Political Economy,$x2945-7084 606 $aAmerica$xPolitics and government 606 $aPolitical science 606 $aRegionalism 606 $aEconomic development 606 $aInternational economic relations 606 $aAmerican Politics 606 $aGovernance and Government 606 $aRegionalism 606 $aDevelopment Studies 606 $aInternational Political Economy' 615 0$aAmerica$xPolitics and government. 615 0$aPolitical science. 615 0$aRegionalism. 615 0$aEconomic development. 615 0$aInternational economic relations. 615 14$aAmerican Politics. 615 24$aGovernance and Government. 615 24$aRegionalism. 615 24$aDevelopment Studies. 615 24$aInternational Political Economy'. 676 $a338.972 700 $aKahn$b Theodore$4aut$4http://id.loc.gov/vocabulary/relators/aut$01060751 906 $aBOOK 912 $a9910338034703321 996 $aGovernment-Business Relations and Regional Development in Post-Reform Mexico$92515516 997 $aUNINA