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Titlebook: Manual of Biobank Quality Management; Agnieszka Matera-Witkiewicz,Joanna Gleńska-Olender Book 2023 Wrocław Medical University 2023 Biobank

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楼主: 实体
发表于 2025-3-28 14:36:19 | 显示全部楼层
Human Resources Management,ppropriate skills to participate in biobanking processes. It also describes development courses as well as the methods of verifying the knowledge of employees during the processing of biological material and related data. In the last part, the chapter . presents how the cooperation with a Biobank employee should be ended.
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Equipment,he acceptance of equipment into the Biobank (installation, operation, and operational qualification) based on the pre-defined criteria, important issues relating to its daily operation, including maintenance, records, documentation, continuous supervision, and work with devices that do not meet the requirements.
发表于 2025-3-29 03:34:44 | 显示全部楼层
Traceability,bles the full identification of biological material and related data received in and issued from the Biobank. It also applies to the unique labeling of biological material and data, which allows them to be identified at every stage of their life cycles.
发表于 2025-3-29 09:46:31 | 显示全部楼层
Biobanking Processes and Quality Control,d are reliable. This chapter describes the life cycle of biological material, taking into account critical technological processes, including the collection, transport, reception, qualification, acceptance, processing, storage, and distribution of biological material and related data, as well as the quality control process.
发表于 2025-3-29 14:49:59 | 显示全部楼层
Deviations, Nonconforming Product/Data or Service,ntation was also descried in detail in the prepared study. The chapter presents numerous practical examples, guidelines for action, and forms, such as a nonconformance card template, which the Biobank can implement and use in its activities.
发表于 2025-3-29 16:30:57 | 显示全部楼层
Audits, important aspects of internal audits in the Biobank and discusses all key stages and best practices, including the process of creating an audit program, preparation for audits, performance and documentation of audit procedures, as well as post-audit activities. In addition, this section describes the competence and qualifications of auditors.
发表于 2025-3-29 23:19:16 | 显示全部楼层
发表于 2025-3-30 01:55:56 | 显示全部楼层
Management of Biobanks, external communication process, including, among other things, the flow of information, the principles of issuing documents inside and outside Biobank as well as the principles of communication with external organizations and stakeholders (including research participants).
发表于 2025-3-30 07:29:51 | 显示全部楼层
Quality Management,ivities, and ultimately improve the quality of work. They also make it possible to control and monitor the progress of activities. The risk and opportunity management allows the Biobank to properly manage its processes and, consequently, to effectively achieve its objectives.
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