LEADER 04462nam 22005895 450 001 9910659489403321 005 20251008135015.0 010 $a3-031-12559-2 024 7 $a10.1007/978-3-031-12559-1 035 $a(MiAaPQ)EBC7194604 035 $a(Au-PeEL)EBL7194604 035 $a(CKB)26130494000041 035 $a(DE-He213)978-3-031-12559-1 035 $a(PPN)268208778 035 $a(EXLCZ)9926130494000041 100 $a20230214d2023 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aManual of Biobank Quality Management /$fby Agnieszka Matera-Witkiewicz, Joanna Gle?ska-Olender, Izabela Uhrynowska-Tyszkiewicz, Ma?gorzata Wito?, Karolina Zagórska, Katarzyna Ferdyn, Micha? Laskowski, Patrycja Sitek, B?a?ej Marciniak, Jakub Pawlikowski, Dominik Strapagiel 205 $a1st ed. 2023. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2023. 215 $a1 online resource (160 pages) 311 08$aPrint version: Matera-Witkiewicz, Agnieszka Manual of Biobank Quality Management Cham : Springer International Publishing AG,c2023 9783031125584 320 $aIncludes bibliographical references. 327 $aChapter 1. Management of Biobanks -- Chapter 2. Quality Management -- Chapter 3. Documentation and Records -- Chapter 4. Human Resources Management -- Chapter 5. Ethical and Legal Aspects -- Chapter 6. Supplies, Materials Management -- Chapter 7. Equipment -- Chapter 8. Traceability -- Chapter 9. Environmental and Staff Hygiene -- Chapter 10. Biobanking Processes and Quality Control -- Chapter 11. Deviations, Nonconforming Product/Data or Service -- Chapter 12. Audits -- Chapter 13. Improvement -- Chapter 14. Biobank Cooperation in the Scientific, Research and Development Area -- Chapter 15. Safety and Security. 330 $aThis pioneering handbook serves as an essential tool for any biobanking entity to create, implement and continuously improve their Quality Management System (QMS). Written in a concise and highly readable manner all biobanking related QMS aspects, ranging from legal aspects to safety matters, are addressed according to the best knowledge in compliance with the dedicated Biobanks ISO standards. Following a practical approach by making use of FAQ and common practice sections this book guides the readers through this complex field in an easy-to understand way. The guidelines are convergent not only with ISO 20387:2018 Biotechnology - Biobanking - General requirements for biobanking but also with ISO 9001:2015, ISO 19011:2018, ISO 27000:2014, and ISO 27002:2013. Furthermore, they are compatible, among others with the recommendations of the Organization for Economic Cooperation and Development (OECD), IARC, and ISBER Best Practices. Aimed at both biobankemployees and other stakeholders (e.g. public bodies, political bodies, hospitals, pharmaceutical industry, funders) at any level of experience the book serves as valuable source for self-education and teaching. The manual complies to the principles of responsibility, openness, and transparency and can be used by any biobanking unit regardless of the biological material the biobank operates with and independent of their associated biobank network. On behalf of a group of specialists and experts in the area of biobanking, regarding Quality Management Systems (QMS), Ethical, Legal and Societal Issues (ELSI) and IT solutions, the authors present with this book a significant achievement based on activities within the project, European Research Infrastructure BBMRI-ERIC ?Quality Standards for Polish Biobanks? Handbook (QSPB). 606 $aBiotechnology 606 $aBiology$xTechnique 606 $aMedicine$xResearch 606 $aBiology$xResearch 606 $aBiotechnology 606 $aBiological Techniques 606 $aBiomedical Research 615 0$aBiotechnology. 615 0$aBiology$xTechnique. 615 0$aMedicine$xResearch. 615 0$aBiology$xResearch. 615 14$aBiotechnology. 615 24$aBiological Techniques. 615 24$aBiomedical Research. 676 $a570.752 700 $aMatera-Witkiewicz$b Agnieszka$01312166 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910659489403321 996 $aManual of Biobank Quality Management$93030764 997 $aUNINA