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姓名 苗舜菖(Shun-Chang Miao) 查詢紙本館藏 畢業系所 網路學習科技研究所 論文名稱 個案研究:利用認知學徒制幫助台灣製藥培訓電腦化系統確效
(Case study: an investigation of utilizing cognitive apprenticeship to help computerized system validation of pharmaceutical manufacturing training in Taiwan)相關論文 檔案 [Endnote RIS 格式]
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摘要(中) 在台灣許多製藥公司不能夠為員工提供良好的在職培訓,且大多數藥廠甚至外部培訓公司使用的教學方式都是使用單向且較低互動的講述教學法,雖然看似已經進行了人員培訓,但效果其實不彰,進而導致員工專業技能缺乏發展且間接影響公司發展,美國食品衛生管理局(FDA)也曾因為藥廠培訓類型的缺失進一步開出了警告信(Warning Letter)。
電腦化系統確效雖然在台灣有不少單位使用講述教學法開設課程,但依據台灣衛生福利部所發表的文獻卻發現電腦化系統確效類型缺失有逐年增長的趨勢。基於以上因素,本研究採用單一個案研究法,並採用跨參與者多重介入(multiple intervention study)的研究設計,以五位現任於不同部門單位的生技產業員工擔任研究對象。
本研究目的在探討認知學徒制以及講述教學法對於台灣製藥業電腦化系統確效之訓練的差異,包含學習成效以及風險評估。因此,本研究採用兩種介入方案間的比較,使用前測、各階段課後評量和深度訪談瞭解研究對象的學習歷程,以及對於兩種教學方式的看法。最後並實施專家實地稽核確保研究對象能解決其任職單位之問題。
依據實驗結果探討本研究提出的結論為:使用認知學徒制可以有效的建立研究對象風險評估的觀念、在電腦化系統生命週期管理的知識有所成長。並能有效的培養研究對象解決問題的能力,經過8周的實驗課程後,研究對象已能夠正確的改善所遇到的問題。
本研究並一併發展一套有助於電腦化系統確效的實作課程教學模式及流程。有助於此技術之發展與推廣。摘要(英) In Taiwan, the pharmaceutical companies generally could not provide adequate on-job training to their employees since the training by the company itself or outside resources mostly utilize traditional unidirectional teaching with a low percentage of interaction between the trainer and trainees. It looks like training has been successfully conducted but the outcome is ineffective, resulting in employees lack of professional techniques and development, and then indirectly affecting the company’s growth. The U.S. Food and Drug Administration (FDA) had once issued Warning Letter to a pharmaceutical company due to an observation in ineffective training.
There are a number of institution giving classes for Computerized System Validation using traditional pedagogy, but the Computerized System Validation type of observations resulting from regulatory authority inspections are growing annually according to documents published by the Taiwan Food and Drug Administration. Based on the above circumstance, this research utilizes a case study method and using multiple intervention study design, to have five participants from different departments in one Biotechnology/Pharmaceutical company to participate. The purpose is to discuss the effect of Cognitive Apprenticeship and traditional pedagogy to Computerized System Validation teaching in Taiwan Pharmaceutical companies. Therefore, this research used more than two intervention methods for comparison, using pre-test, post-testing after lecture, and in-depth interview to help understands the progress of learning from the participants and their opinion on the two types of teaching method. Finally, to perform external site audits to ensure that participants can solve the Computerized System Validation related problem within their department.
From the test result, the discussion of the purpose of this research concludes that:
Using Cognitive Apprenticeship teaching method could have significant correlation to the trainee establishing risk assessment methodology and knowing how the Computerized system lifecycle management works from a practical aspect. Using Cognitive Apprenticeship teaching method could help the trainee establish question solving abilities and improve the actions taken when encountering a problem after the 8 weeks long training course.
This research has developed a set of practical teaching module and procedure that is helpful for the Computerized System Validation topic, which aids in the related development and promoting of this technique.關鍵字(中) ★ 電腦化系統確效
★ 認知學徒制
★ 藥品製造培訓
★ 在職訓練關鍵字(英) ★ Computerized System Validation
★ Cognitive Apprenticeship
★ Pharmaceutical manufacturing training
★ On-the-job Training論文目次 摘要 i
Abstract ii
致謝 iv
目錄 v
圖目錄 viii
表目錄 ix
第一章 緒論 1
1-1 研究背景與動機 1
1-2 研究目的 4
1-3 研究問題 4
1-4 研究步驟 5
1.4.1 準備階段 5
1.4.2 實驗教學階段 7
1.4.3 分析研究結果階段 8
1-5 研究問題 10
1-6 名詞釋義 10
1.6.1 認知學徒制(Cognitive Apprenticeship) 10
1.6.2 電腦化系統(Computerized System) 11
1.6.3 電腦化系統確效(Computerized System Validation) 12
1.6.4 GxP規範 12
1.6.5 講述教學法(Didactic Teaching) 12
第二章 文獻探討 13
2-1 認知學徒制的源起與特色 13
2-2 認知學徒制之教學方法 14
2-3 認知學徒制應用於職場教學 16
2.3.1 示範、指導,鷹架,反思對各領域教學的相關研究及發現 17
2-4 電腦化系統確效(Computerized System Validation)核心觀念 18
2-5 製藥產業及電腦化系統確效的人員培訓現況 19
2-6 小結 20
第三章 實驗設計 21
3-1 研究變數的架構 21
3-2 研究對象與電腦化系統確效角色關係 22
3-3 研究限制 22
3-4 實驗設計 23
3.4.1 實驗效度 24
3-5 課程設計 24
3.5.1 教學目標 24
3.5.2 教學方法及內容 25
3.5.3 研究工具 26
第四章 研究結果 27
4-1 不同教學方法對電腦化系統確效教學成效之描述分析 27
4.1.1 整體教學成效 27
4.1.2 電腦化系統確效各面向教學成效 29
4.1.3 電腦化系統確效基礎知識(CSV Basic Knowledge)學習成效 30
4.1.4 電腦化系統生命週期管理(Lifecycle management)學習成效 33
4.1.5 資料完整性(Data Integrity)學習成效 35
4.1.6 風險評估(Risk Assessment)學習成效 37
4-2 實施專家稽核 - 研究對象單位實地稽核結果 38
4.2.1 專家稽核標準 39
4.2.2 課程後實作成果 40
4.2.3 專家稽核結果 43
4-3 訪談資料分析結果 45
4.3.1 研究對象現任職位/工作內容描述 45
4.3.2 研究對象對於電腦化系統確效相關經驗及自我評估 46
4.3.3 研究對象參加此課程的動機層面 46
4.3.4 對於此次實驗課程的了解以及喜好 47
4.3.5 認知學徒制示範(Modeling)階段對於幫助電腦化系統確效學習的看法 49
4.3.6 認知學徒制指導(Coaching)階段對於幫助電腦化系統確效學習的看法 49
4.3.7 認知學徒制鷹架(Scaffolding)階段對於幫助電腦化系統確效學習的看法 50
4.3.8 認知學徒制反思(reflection)階段對於幫助電腦化系統確效學習的看法 51
4.3.9 認知學徒制闡明(articulation)與探索(exploration)階段對於幫助電腦化系統確效學習的看法 51
4.3.10 認知學徒制和講述教學的比較 52
4.3.11 針對每節課後評量的討論 54
4.3.12 影響學習成效的因素 55
4.3.13 訪談結果小結 56
4-4 綜合討論 57
4.4.1 不同教學方法對電腦化系統確效不同面向之教學成效 57
4.4.2 專家稽核結果對於研究問題的對比 59
4.4.3 認知學徒制和講述教學法分別對電腦化系統確效各別的成效 59
第五章 結論與建議 62
5-1 結論 62
5-2 建議 64
5-3 電腦化系統確效教學之建議 64
5-4 後續研究之建議 65
附錄一:前測試卷-階段A 71
附錄二:課後評量試卷-階段B1 73
附錄三:課後評量試卷-階段C1 74
附錄四:課後評量試卷-階段B2 75
附錄五:課後評量試卷-階段C2 76
附錄六:課後評量試卷-階段B3 77
附錄七:課後評量試卷-階段C3 79
附錄八:課後評量試卷-階段B4 80
附錄九:課後評量試卷-階段C4 81
附錄十:訪談大綱 82
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