000			03656nam a2200337 i 4500
999			_c399489 _d399489
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003			ES-MaUEC
005			20240429113240.0
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007			cr nn 008mamaa
008			230214s2023 sz | fo |||| 0|eng d
020			_a9783031125591
024	7		_a10.1007/978-3-031-12559-1 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aTP248.2 _b2023 EB
100	1		_aMatera-Witkiewicz, Agnieszka _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut _9690165
245	1	0	_aManual of Biobank Quality Management _cby Agnieszka Matera-Witkiewicz [y otros diez]
250			_a1st ed. 2023
264		1	_aCham _bSpringer International Publishing _c2023
300			_a1 recurso en línea
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
505	0		_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.
520			_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 biobank employees 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).
988			_aSpringer_BiomedLife_2023
650		7	_2embne _9140931 _aBiotecnología
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-031-12559-1 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b04/2024 _dz _eb _zSI