|
|
|
|
| LEADER |
07505nam a22004573i 4500 |
| 001 |
EBC6483075 |
| 003 |
MiAaPQ |
| 005 |
20231204023215.0 |
| 006 |
m o d | |
| 007 |
cr cnu|||||||| |
| 008 |
231204s2021 xx o ||||0 eng d |
| 020 |
|
|
|a 9783030644925
|q (electronic bk.)
|
| 020 |
|
|
|z 9783030644918
|
| 035 |
|
|
|a (MiAaPQ)EBC6483075
|
| 035 |
|
|
|a (Au-PeEL)EBL6483075
|
| 035 |
|
|
|a (OCoLC)1240210401
|
| 040 |
|
|
|a MiAaPQ
|b eng
|e rda
|e pn
|c MiAaPQ
|d MiAaPQ
|
| 050 |
|
4 |
|a RC633-647
|
| 100 |
1 |
|
|a Aljurf, Mahmoud.
|
| 245 |
1 |
0 |
|a Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy :
|b The JACIE Guide.
|
| 250 |
|
|
|a 1st ed.
|
| 264 |
|
1 |
|a Cham :
|b Springer International Publishing AG,
|c 2021.
|
| 264 |
|
4 |
|c ©2021.
|
| 300 |
|
|
|a 1 online resource (189 pages)
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a computer
|b c
|2 rdamedia
|
| 338 |
|
|
|a online resource
|b cr
|2 rdacarrier
|
| 505 |
0 |
|
|a Intro -- 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 -- Introductıon -- 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 |
|
|a Third-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 |
|
|a Qualification 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 |
|
|a Correction to: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy -- Correction to: -- Index.
|
| 588 |
|
|
|a Description based on publisher supplied metadata and other sources.
|
| 590 |
|
|
|a Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2023. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
|
| 655 |
|
4 |
|a Electronic books.
|
| 700 |
1 |
|
|a Snowden, John A.
|
| 700 |
1 |
|
|a Hayden, Patrick.
|
| 700 |
1 |
|
|a Orchard, Kim H.
|
| 700 |
1 |
|
|a McGrath, Eoin.
|
| 776 |
0 |
8 |
|i Print version:
|a Aljurf, Mahmoud
|t Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy
|d Cham : Springer International Publishing AG,c2021
|z 9783030644918
|
| 797 |
2 |
|
|a ProQuest (Firm)
|
| 856 |
4 |
0 |
|u https://ebookcentral.proquest.com/lib/matrademy/detail.action?docID=6483075
|z Click to View
|
