開課講師｜林逸宭
課程資訊｜2025.10.18-5
報名方式｜線上報名
課程介紹｜
本次經驗分享將探討人體器官保存庫在教育訓練、人員資格與授權機制方面的要求與實務。
內容將說明人體細胞組織優良操作規範與AATB標準在人員教育訓練的相關要求及原則。在討論中也將分享教育訓練、考核與紀錄的實務範例，確保人員的能力(說、寫、作一致)，並能有效追蹤教育訓練的結果。最後，我們建議參考 ISO 13485 和 PIC/S GMP 等國際品質標準，建構全面的「培訓+授權」流程。此流程旨在實現人體器官保存庫的合規性和品質管理，確保其符合多項國際標準並實現內部實施。
Practical Experience in Training, Qualification and Authorization of Tissue Bank Staffs
This presentation will be an experience sharing session focusing on the implementation of staff training, qualification, and authorization within the Tissue Bank at ECM Biomedical. The presentation will start from introducing the requirements of training in the Good Tissue Practice (GTP) and AATB standards. Followed by several examples on training, evaluation, and documentation which is to demonstrate staff competency (consistency between saying, writing, and doing). Lastly, the training requirements in the international quality standards, such as ISO 13485 and PIC/S GMP, will be used to establish a more comprehensive "Training + Authorization" process. This process intends to align the tissue bank's training functions with the same functions in more robust quality systems.
講師介紹｜
