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。 ;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.
