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

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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)

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至系統瀏覽論文 (2024-7-19以後開放)

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
附錄十一: 研究對象於電腦化系統確效中的角色關係與權責 86

參考文獻

行政院衛生署 (2013)。西藥藥品優良製造規範第二部(原料藥)。
行政院衛生署 (2002)。現行藥品優良製造規範－電腦化系統確效指導手冊。
吳清山、林天祐 (1999)。教育名詞：教育指標。教育資料與研究，88，145-146。
周春美 (2010)。技專校院商科教師教學實務之應用分析：認知學徒制的觀點。商管科技季刊，11（2），303-313。
秦垚, & 梁毅 (2016)。基于 GAMP5 的我国制药企业计算机化系统验证的应用研究. 机电信息, (17), 1-11.
陳聖謨（1999）。國民小學教師教學反省之研究。國立高雄師範大學，高雄市。
陳詩穎、顏宏家、謝綺雯、王淑芬、李明鑫 (2017)。國內藥廠持續性安定性試驗專案查核結果分析. Ann. Rept. Food Drug Res, 8, 302-308。
鈕文英, & 吳裕益 (Eds.) (2015)。單一個案研究法: 研究設計與後設分析. 心理。
衛生福利部食品藥物管理署 (2019)。GMP/GDP數據管理及完整性指導手冊. Retrieved June 2021, from https://tcmia.org.tw/upload/fckimages/file/108.08.06_20190820_1.pdf
衛生福利部食品藥物管理署 (2021)。GMP藥廠名單. Retrieved from https://www.fda.gov.tw/TC/siteListContent.aspx?sid=2067&id=3475&chk=5b6f2ebd-8ed2-46ee-a17b-f7c7517bbaf0
謝茉莉、洪利穎、黃雅文 (2015)。運用鷹架理論的醫病溝通課程 ‧人文社會與醫療學刊， 2(1)，25-39。
簡紅珠 (2000)。講述教學法 Didactic Teaching. Retrieved June 2000, from https://terms.naer.edu.tw/detail/1315014/?index=40
Bareiss, R., & Radley, M. (2010, March). Coaching via cognitive apprenticeship. In Proceedings of the 41st ACM technical symposium on Computer science education (pp. 162-166).
Boni, A. A., Weingart, L. R., & Evenson, S. (2009). Innovation in an academic setting: Designing and leading a business through market-focused, interdisciplinary teams. Academy of Management Learning & Education, 8(3), 407-417.
Brandt, B. L., Farmer Jr, J. A., & Buckmaster, A. (1993). Cognitive apprenticeship approach to helping adults learn. New directions for adult and continuing education, 1993(59), 69-78.
Brown, J. S., Collins, A., & Duguid, P. (1989). Situated cognition and the culture of learning. Educational researcher, 18(1), 32-42.
Cader, H. A., & Norman, D. W. (2006). 15. Entrepreneurship education for the African informal sector. International entrepreneurship education, 277.
Charney, J., Hmelo‐Silver, C. E., Sofer, W., Neigeborn, L., Coletta, S., & Nemeroff, M. (2007). Cognitive apprenticeship in science through immersion in laboratory practices. International Journal of Science Education, 29(2), 195-213.
Dewey, J. (1902). The child and the curriculum. Chicago: The University of Chicago Press
Dickey, M. D. (2008). Integrating cognitive apprenticeship methods in a Web-based educational technology course for P-12 teacher education. Computers & Education, 51(2), 506-518.
FDA, U. (1987). Guideline on general principles of process validation. Guide Indus May.
FDA’s office of regulatory affairs. (2020, November 24). Inspection Observations. Retrieved from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations
GAMP, I. (2008). 5: a risk-based approach to compliant GXP computerized systems. ISPE, Tampa, FL.
Hafeez, U., & Akbar, W. (2015). Impact of training on employees performance (Evidence from pharmaceutical companies in Karachi, Pakistan). Business Management and strategy, 6(1), 49-64.
Lave, J., & Wenger, E. (1991). Situated learning: Legitimate peripheral participation. Cambridge, UK: Cambridge university press.
Levchuk, J. W. (1991). Training for GMPs. PDA Journal of Pharmaceutical Science and Technology, 45(6), 270-275.
Maigida, J. F. (2016). Effect of Cognitive Apprenticeship Instructional Method on Students’ Acheivement, Retention and Skill Performance in Automobile Mechanics (Doctoral dissertation).
Martin, K. C., & Perez, A. (2008). GAMP 5 quality risk management approach. Pharmaceutical Engineering, 28(3), 24.
Osterman, K. F., & Kottkamp, R. B. (1993). Reflective practice For educators: Improving schooling through professional development. New bury Park CA: Corwin Press.
Pai, D. R., Kamath, K., Subramanyam, E. V. S., & Shabaraya, A. R. (2016). Personnel Training for Pharmaceutical Industry. International Journal of Pharmaceutical Quality Assurance, 7(03), 55-61.
Rogoff, B. (1990). Apprenticeship in thinking: Cognitive development in social context. New York, NY: Oxford University Press.
Scheme, P. I. C. O. (2007, September). Good Practices for Computerised Systems in Regulated “Gxp” Environments. In Pharmaceutical Inspection Convention, PI (pp. 011-1).
SCHEME, P. I. C. O. (2018). GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART II.
Seezink, A., Poell, R. F., & Kirschner, P. A. (2009). Teachers’ individual action theories about competence‐based education: the value of the cognitive apprenticeship model. Journal of Vocational Education and Training, 61(2), 203-215.
Smerdon, B., Burkham, D., & Lee, V. (1999). Access to constructivist and didactic teaching: Who gets it? Where is it practiced?. Teachers college record, 101(1), 5-34.
Tawney, J.W. , & Gast, D.L. (1984). Single subject research in special education. Columbus, OH: Merrill.
US Food and Drug Administration, & US Food and Drug Administration. (21). CFR Part 11: Electronic Records; Electronic Signatures.
Wilson, B. G., Jonassen, D. H., & Cole, P. (1993). Cognitive approaches to instructional design. The ASTD handbook of instructional technology, 4, 21-21.
Wingate, G. (Ed.). (2016). Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance.

指導教授

黃武元(Wu-Yuan Hwang)

審核日期

2021-8-18

推文