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Page 1 of 38 FOO D AND DRUG ADMINISTRATION COMPLIANC E PROGRA M GUIDANC E MANUA L PROGRA M 7356.002A CHAPTER 56 ΠDRUG QUALITY ASSURANCE SUBJEC T: STERILE DRUG PROCESS INSPECTIONS Revision Note: Program revised 09/11/2015 to update implementation date, completion date, organizational/procedural changes and program contacts. IMPLEMEN TATION DATE September 11 , 2015 COMPLE TION DATE September 11, 2016 DATA REPOR TING PRODUC T CODES PRODUC T/ASSIGNMEN T CODES Industry codes 54, 56 and 60 -66 inclusive Domestic / Foreign Inspections: 56002A (Full Inspection) 56002I (Abbreviated Inspection) Related PACs 56002 56002C 56002M FIEL D REPORTIN G REQUIREMENTS: Establishment Inspection Reports (EIRs) are to be created and filed electronically using the specific module in TurboEIR or replacement system that is accessible to both ORA and CDER. For inspections of routine commercial manufacturing classified as Official Action Indicated (OAI) due to failure to comply with 21 CFR Part 210 and 211 Current Good Manufacturing Practice (CGMP) as they apply to sterile drug process inspections , submit adv isory, administrative, or judicial action recommendations via MARCS -CMS in accordance with the Regulatory Procedures Manual (RPM). Districts should immediately report significant issues according to current FACTS, Panorama and CMS procedures. This includes promptly filing and changing OAI notifications. During an inspection, if you obtain information pertaining to inadequate adverse drug experience (ADE) reporting, unapproved drug issues, or post -approval reporting violations (application supplements, Field Alert Reports (FARs), etc.), report in accordance with directions provided in the applicable compliance programs and under separate captions in the EIR. Data system information about these inspectional activities should be reported under separate Program Assignment Codes (PACs). Expansion of coverage under these programs into a CGMP inspection should be reported under this compliance program.

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The number of pages within the document is: 64

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141MONEY LAUNDERING AND BULK CASH SMUGGLING: CHALLENGES FOR THE MÉRIDA INITIATIVE Douglas Farah THE SCOPE OF THE PROBLEM It is widely accepted that cutting o thw of money from the sale of cocaine in the United States to the Mexican drug tracking organizations is one of the most ecient ways to decrease the power of the cartels. Without the cash inx there would be less money for corruption and the purchase of weapons, and cash seizures directly take away what the drug trackers want most — prs from their illicit activities. On both sides of the border the smuggling of bulk cash and money laundering tied to the billions of dollars in prs is not just viewed as a problem for Mexico, but as a signicant security threat to the United States. Parts of Mexico have seen the homicide rate skyrocket in recent years, particularly Ciudad Juárez. The Calderón administration has felt obligated to deploy the military to support and in some cases supplant local law enforcement because of the strength of the cartels and the deep seated corruption among the law enforcement and judicial structures. “The prevention of money laundering and thnancing of terror are today a matter of high priority, both nationally and internationally because they concern complex phenomena with serious economic and social consequences because they allow organized crime tonance criminal activities,” said a recent Mexican policy statement. “These activities generate public insecurity and social destabilization and can severely damage the reputatinancial sectors and the country itself.” 1The 2009 National Drug Threat Assessment of the U.S. Department of Justice (NDIC report) described Mexican drug tracking organizations as “the greatest orga- nized crime threat to the United States.” 2 The report found that drug tracking orga- nizations place a high priority on legitimizing the proceeds of their drug sales and that “bulk cash is a prominent method” for Mexican organizations to move their cash. 3Given the stated priorities of both governments to enhance the money laundering structures and halt bulk cash shipments, it is striking that direct funding for such 1“Tipologías Del GAFI Aplicables a Los Sectores Asegurador y de Remesas,” Unidad de Inteligencia Financiera, Secretaría de Hacienda y Crédito Público Informe 2009. 2“National Drug Threat Assessment 2009,” National Drug Intelligence Center, Department of Justice, January 2009, p. 43. 3“National Drug Threat Assessment 2009,” op cit ., p. 45.

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The number of pages within the document is: 206

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Friedrich Engels

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2019-02-09 18:59:40.573098

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Friedrich Engels Condition of the Working Class in England Written: September 1844 to March 1845; Source: Panther Edition, 1969, from text provided by the Institute of Marxism -Leninism, Moscow; First Published: Leipzig in 1845; The English edition (authori sed by Engels) was published in 1887 in New York and in London in 1891; Transcription/Markup: Zodiac Tim Delaney in 1998; Proofed and corrected by Mark Harris, 2010. Table of Contents Preface to the American Edition …………………………………………………………………………………….. 2 The Labor Movement in America …………………………………………………………………………………… 2 Preface to the English Edition ………………………………………………………………………………………… 8 Preface to the Second German Edition (1892) ………………………………………………………………… 19 To The Working -Classes of Great -Britain ……………………………………………………………………… 29 Preface ………………………………………………………………………………………………………………………. 31 Introduction ……………………………………………………………………………………………………………….. 33 The Industrial Proletariat ……………………………………………………………………………………………… 42 The Great Towns ………………………………………………………………………………………………………… 44 Competition ……………………………………………………………………………………………………………….. 73 Irish Immigration ………………………………………………………………………………………………………… 81 Results ………………………………………………………………………………………………………………………. 84 Single Branches of Industry ……………………………………………………………………………………….. 106 Factory -Hands ……………………………………………………………………………………………………… 106 The Remaining Branches of Industry …………………………………………………………………………… 136 Labour Movements ……………………………………………………………………………………………………. 150 The Mining Proletariat ………………………………………………………………………………………………. 165 N O T I C E! Pentrich Colliery ………………………………………………………………………… 172 The Agricultural Proletariat ………………………………………………………………………………………… 175 The Attitude of the Bourgeoisie Towards the Proletariat ………………………………………………… 183 An English Turnout …………………………………………………………………………………………………… 195 1886 Appendix to the American Edition ………………………………………………………………………. 203

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The number of pages within the document is: 319

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Evelyn Nakano Glenn

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2019-02-09 15:37:46.215880

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2019-02-09 18:05:03.539567

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The Shaping Influences of ‚A Capable Person:™ A Narrative Research of Elders™ Stories of Raisi ng Children to Inform Aboriginal Education in the Northwest Territories by V. Angela James M.A. (Education Leadership ), San Diego State University, 2003 B.Ed., University of Manitoba, 1989 Thesis Submitted in Partial Fulfillment of the Requirements for the Degree of Doctor of Education in the Transformational Change Program Faculty of Educatio n V. Angela James 2016 SIMON FRASER UNIVERSITY Summer 2016

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The number of pages within the document is: 130

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Albert Eugene Novark

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2019-02-09 17:48:53.167628

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University of Massachusetts – AmherstScholarWorks@UMass AmherstOpen Access DissertationsDissertations and Theses2-1-2011Hardening Software Against Memory Errors andAttacksAlbert Eugene NovarkUniversity of Massachusetts – AmherstThis Dissertation is brought to you for free and open access by the Dissertations and Theses at ScholarWorks@UMass Amherst. It has been acceptedfor inclusion in Open Access Dissertations by an authorized administrator of ScholarWorks@UMass Amherst. For more information, please contactscholarworks@library.umass.edu.Recommended CitationNovark, Albert Eugene, “Hardening Software Against Memory Errors and Attacks” (2011).Open Access Dissertations.Paper 346.http://scholarworks.umass.edu/open_access_dissertations/346

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CHAPTER ICHAPTER IICHAPTER IIICHAPTER IVCHAPTER VCHAPTER VICHAPTER VIICHAPTER VIIICHAPTER IXCHAPTER XCHAPTER XICHAPTER XIICHAPTER XIIICHAPTER XIVCHAPTER XVCHAPTER XVIChapter XVIIICHAPTER XVIICHAPTER XVIIICHAPTER XIXCHAPTER XXCHAPTER XXICHAPTER XXIICHAPTER XXIIICHAPTER XXIVCHAPTER XXVCHAPTER XXVICHAPTER XXVIICHAPTER XXVIIICHAPTER XXIXCHAPTER XXXCHAPTER XXXIPart III, Annual Report of the Secretary of Internal1

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ThePoems ofEmily Dickinson With an Introduction by Martha Dickinson Bianchi A Penn State Electronic Classics Series Publication

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Iranian Cultural Heritage, Handicrafts and Tourism Organization EXECUTIVE SUMMARY TABRIZ HISTORICAL BAZAAR COMPLEX UNESCO World Heritage Convention Nomination of Properties for Inclusion on The World Heritage List Tehran 2009

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