000			07911nam a22004693i 4500
001			EBC6483075
003			MiAaPQ
005			20220324112739.0
006			m o d |
007			cr cnu||||||||
008			220324s2021 xx o ||||0 eng d
020			_a9783030644925 _q(electronic bk.)
020			_z9783030644918
035			_a(MiAaPQ)EBC6483075
035			_a(Au-PeEL)EBL6483075
035			_a(OCoLC)1240210401
040			_aMiAaPQ _beng _erda _epn _cMiAaPQ _dMiAaPQ
050		4	_aRC633-647
100	1		_aAljurf, Mahmoud.
245	1	0	_aQuality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy : _bThe JACIE Guide.
264		1	_aCham : _bSpringer International Publishing AG, _c2021.
264		4	_c�2021.
300			_a1 online resource (189 pages)
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
505	0		_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.
505	8		_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.
505	8		_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.
505	8		_aCorrection to: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy -- Correction to: -- Index.
588			_aDescription based on publisher supplied metadata and other sources.
590			_aElectronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2022. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
655		4	_aElectronic books.
700	1		_aSnowden, John A.
700	1		_aHayden, Patrick.
700	1		_aOrchard, Kim H.
700	1		_aMcGrath, Eoin.
776	0	8	_iPrint version: _aAljurf, Mahmoud _tQuality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy _dCham : Springer International Publishing AG,c2021 _z9783030644918
797	2		_aProQuest (Firm)
856	4	0	_uhttps://www.nbs.de/bibliothek/faq _zWie greife ich auf das E-Book zu?
856	4	0	_uhttps://ebookcentral.proquest.com/lib/nbsde/detail.action?docID=6483075 _zClick to View
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