LEADER 00804nam0-22002771i-450- 001 990005071160403321 005 19990530 035 $a000507116 035 $aFED01000507116 035 $a(Aleph)000507116FED01 035 $a000507116 100 $a19990530g19629999km-y0itay50------ba 101 0 $aita 105 $af---a---00--- 200 1 $a<>bibliography of Lucretius$fCosmo Alexander Gordon 210 $aLondon$cR. Hart-Davis$d1962. 215 $a318 p., [18] c. di tav.$d23 cm 700 1$aGordon,$bCosmo Alexander$0203098 702 1$aLucretius Carus,$bTitus$f<97-55 a. C.> 801 0$aIT$bUNINA$gRICA$2UNIMARC 901 $aBK 912 $a990005071160403321 952 $aVII C 71$bBibl. 37317$fFLFBC 959 $aFLFBC 996 $aBibliography of Lucretius$9531774 997 $aUNINA LEADER 01284nam 22004213 450 001 9910502672303321 005 20211214151244.0 010 $a981-16-4388-1 035 $a(CKB)4100000012037265 035 $a(MiAaPQ)EBC6735626 035 $a(Au-PeEL)EBL6735626 035 $a(OCoLC)1281956648 035 $a(EXLCZ)994100000012037265 100 $a20211214d2021 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aDC--DC Converters for Future Renewable Energy Systems 210 1$aSingapore :$cSpringer Singapore Pte. Limited,$d2021. 210 4$d©2022. 215 $a1 online resource (480 pages) 225 1 $aEnergy Systems in Electrical Engineering Ser. 311 $a981-16-4387-3 410 0$aEnergy Systems in Electrical Engineering Ser. 608 $aElectronic books. 700 $aPriyadarshi$b Neeraj$01073675 701 $aBhoi$b Akash Kumar$0966330 701 $aBansal$b Ramesh C$0916993 701 $aKalam$b Akhtar$0929704 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910502672303321 996 $aDC--DC Converters for Future Renewable Energy Systems$92569839 997 $aUNINA LEADER 09314nam 22008893 450 001 9910473450803321 005 20251017110139.0 010 $a3-030-64492-8 035 $a(CKB)4100000011774012 035 $a(MiAaPQ)EBC6483075 035 $a(Au-PeEL)EBL6483075 035 $a(OCoLC)1240210401 035 $a(oapen)https://directory.doabooks.org/handle/20.500.12854/64034 035 $a(PPN)253861845 035 $a(ODN)ODN0010072959 035 $a(oapen)doab64034 035 $a(DNLM)9918367971806676 035 $a(EXLCZ)994100000011774012 100 $a20210901d2021 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aQuality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy $eThe JACIE Guide 205 $a1st ed. 210 $cSpringer Nature$d2021 210 1$aCham :$cSpringer International Publishing AG,$d2021. 210 4$d©2021. 215 $a1 online resource (189 pages) 225 1 $aMedicine Series 311 08$a3-030-64491-X 327 $aIntro -- Introduction -- Contents -- Contributors -- Chapter 1: Quality and Standards for Haematopoietic Stem Cells Transplantation Programs -- Quality -- Standards -- Impact -- Conclusion -- References -- Chapter 2: Development of Organizational Quality Management System -- References -- Chapter 3: Document Development, Implementation, Review, Archive, and Disposal -- General -- Start -- Workflow -- Responsibilities -- Duplication of Requirements Between Different Quality Systems -- ICT Systems and Paper Documents -- Education and Document Management -- JACIE on Document Management -- Chapter 4: Audits -- General Concepts -- Definition and Purpose -- Scope -- Types of Audits -- Auditor Requirements -- How to Perform Internal Audit: The Steps of an Internal Audit -- Audit Calendar -- Audit Plan -- Conducting the Audit -- Closing -- Audit Report -- Actions -- Communication of the Result of Internal Audits -- References -- Chapter 5: Qualification and Validation -- Glossary -- Validation Process (Fig. 5.2) -- Example of Documents and Registration Forms for Validation -- Validation Master Plan (VMP) -- Validation Study -- References -- Chapter 6: Outcome Analysis -- What Is Outcome Analysis? -- Standards -- Collecting Data -- Establishing Outcome Analysis for Novel Applications -- Reviewing Data -- References -- Further Reading -- Chapter 7: Personnel Requirements Including Job Descriptions -- Introduct?on -- Organisational Structure and Organisational Chart -- Key Personnel -- Personnel Competency -- Responsibility and Task Awareness -- Use of Effective Communication -- Job Descriptions -- Personnel File -- Conclusion -- References -- Chapter 8: Third-Party Agreements -- Gentlemen's Agreement -- Memoranda of Understanding (MoU) [1] -- Contract/Commercial Agreement (Fig. 8.2) -- Service-Level Agreements (SLAs) -- Technical Agreement. 327 $aThird-Party Agreement -- Quick Checklist [2] -- Communication Is Critical [3] (Fig. 8.4) -- References -- Chapter 9: Performance Measurement -- Definitions for Healthcare Performance Measurement -- Measure Development Life Cycle -- Measure Development Process -- Bringing It All Together -- Performance Score -- Goals for Measure Development in SCT Program -- SCT Program Performance Measure -- Performance Measurement and KPI -- The Value of Dashboards for Metrics or KPI -- Dashboard Basics for Quality (Table 9.4) -- Challenges HCT Programs Can Embrace -- Examples of Quality KPI for Clinical SCT Program (Table 9.5) -- KPI Administrative Focus Areas -- Conclusion -- References -- Chapter 10: Tracking and Traceability -- Introduction -- Information Environment -- Donation Identification -- Combining Donation and Product Information -- References -- Chapter 11: Adverse Events and Corrective and Preventive Actions -- Definitions of What to Report -- Investigation, Analysis -- Corrective, Preventive Action -- Biological Product Deviations (BPD) -- References -- Chapter 12: Process Indicators -- Introduction, Definitions, and Example -- Process Definitions -- Process Controls -- Process Indicators -- Selection, Definition, and Range -- Persons Responsible for the Measure and Timing -- Indicator's Table -- Actions -- Other Indicators -- Indicators Within Time -- Communication -- References -- Chapter 13: Writing a Quality Management Plan -- Introduction -- QMP Structure -- HCT Programme Description -- Organizational Structure - Roles and Responsibilities -- Key Personnel - Qualifications, Training, and Competency -- Document Control -- Key Performance Data and Outcome Analysis -- Audits -- The Management of Products with Positive Microbial Culture Results -- The Management of Occurrences -- Traceability -- Business Continuity Policy. 327 $aQualification and Validation -- General Principles -- Quality Risk Management -- Obtaining Feedback -- Tools for Continuous Quality Improvement -- Other Aspects -- References -- Chapter 14: The Accreditation Process -- Why Seek Accreditation? -- Where to Start? -- Phases of the Accreditation Process -- Pre-inspection Phase -- Application Form -- Self-Assessment Standards Checklist -- Pre-inspection Documentation -- Inspection Phase -- Post-inspection Phase -- Plan the Post-accreditation Period -- Key Agents -- References -- Chapter 15: Data Management -- Data Management -- Conclusion -- References -- Chapter 16: Maintaining the Quality Management Program -- General -- The Setup of the Quality Manual -- Work Area -- Material and Supplies -- Hygiene -- Education -- Documentation -- Changes -- Validation -- Information and Communications Technology (ICT) -- Meetings -- Outcome -- Risk Assessments -- Audits -- Chapter 17: Training Programme -- Types of Education -- Orientation Training -- Initial Training -- Continuous Education -- Training Methods -- Theoretical Education -- Practical Training -- Rotation Training -- Conferences -- Case Training -- Online Training -- Standard Operating Procedure (SOP) Training -- Unplanned Training -- Trainer Qualifications -- Determination of Training Needs -- Documentation of Training -- Training Evaluation -- Conclusion -- References -- Chapter 18: Risk Management -- Defining Risk in Cell Therapy -- The Quality Risk Management Process -- Risk Assessment -- Risk Control -- Risk Review -- Risk Communication -- Stakeholders Involved in Risk Management -- Illustrative Examples of Specific Applications -- Related vs. Unrelated Donors -- Processing of Cell Therapy Products -- Patients -- Final Remarks -- References. 327 $aCorrection to: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy -- Correction to: -- Index. 330 $aThis open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program. 410 0$aMedicine Series 606 $aHaematology$2bicssc 606 $aOncology$2bicssc 610 $aHematology 610 $aOncology 610 $aBlood Transfusion Medicine 610 $aInternal Medicine 610 $aoutcome analysis 610 $astructural indicators 610 $aprocess indicators 610 $aHematopoietic Stem Cell Transplantation 610 $aQuality Management 610 $aAudits 610 $aQualification and Validation 610 $aPersonnel Requirements 610 $aPerformance Measurement 610 $aTracking and Traceability 610 $aAdverse Events 610 $aQuality Management Plan 610 $aAccreditation 610 $aData Management 610 $aTraining 610 $aRisk Management 610 $aJACIE 610 $aHaematology 615 7$aHaematology 615 7$aOncology 686 $aMED038000$aMED062000$2bisacsh 700 $aAljurf$b M. D$g(Mahmoud Deeb).$01830417 701 $aSnowden$b John A$01023203 701 $aHayden$b Patrick$c(Consultant haematologist)$0787613 701 $aOrchard$b Kim H$01023204 701 $aMcGrath$b Eoin$01023205 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910473450803321 996 $aQuality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy$94400744 997 $aUNINA