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Week
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Topics
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Study Metarials
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1
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Duties and responsibilities of the study director
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2
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Good Laboratory Practices Principles of documentation guidelines
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3
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Applying the documentation system in the Principles of Good Laboratory Practices
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4
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Standard Procedure Writing Rules
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5
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Places to be noted in the Standard Procedure Writing Rules
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6
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Application of Standard Procedure Writing Rules
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7
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Organization and Personnel Characteristics and Application of Test Unit
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8
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Key points of the work plan and preparation
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9
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Implementation of study plan and preparation
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10
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Final Report and Preparation
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11
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Planning of auditing in Good Laboratory Practices
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12
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Questions and answers from Good Laboratory Practices
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13
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Points to note when studying working in Good Laboratory Practices.
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14
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Examination of Good Laboratory Practices with examples
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Prerequisites
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-
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Language of Instruction
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Turkish
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Responsible
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Assoc. Prof. Özcan ÖZKAN
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Instructors
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-
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Assistants
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-
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Resources
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1. Resmi Gazete. 2002. Çevre Bakanlığı: İyi Laboratuvar Uygulamaları Prensipleri ve Test Laboratuvarlarının Belgelendirilmesine Dair Yönetmelik.
2. OECD SERIES. 2016. Principles of Good Laboratory Practice (GLP) and Compliance Monitoring. Web sitesi. http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm Erişim Tarihi: 01.10.2016.
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Supplementary Book
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1. Selvakumar, R. 2010. Good Laboratory Practices. Ind J Clin, 25(3), 221 224.
2. Ezzelle et al. 2008. Guidelines on Good Clinical Laboratory Practice: Bridging Operations between Research and Clinical Research Laboratories. J Pharm Biomed Anal, 46(1), 18-29.
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Goals
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The aim of the course is to teach the quality, reliability and standard operating methods of the test data in the laboratory in the context of the Good Laboratory Practice Principles in the biological testing system and to acquire advanced knowledge and skills in their application.
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Content
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Duties and responsibilities of the study director
Good Laboratory Practices Principles of documentation guidelines
Applying the documentation system in the Principles of Good Laboratory Practices
Standard Procedure Writing Rules
Points to note in the Standard Procedure Writing Rules
Application of Standard Procedure Writing Rules
Organization and Personnel Characteristics and Application of Test Unit
Key points of the work plan and preparation
Implementation of the Work Plan and its preparation
Final Report and Preparation
Planning of auditing in Good Laboratory Practices
Questions and Answers from Good Laboratory Practices
Points to note when studying working in Good Laboratory Practices
Examination of Good Laboratory Practices with examples
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Program Learning Outcomes |
Level of Contribution |
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1
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To build a new skills and knowledge on undergraduate
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4
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2
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To use the data in interdisciplinary and professional works.
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4
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3
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To transfer knowledge in interdisciplinary studies
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5
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4
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To win the knowledge and skills that will make someone successful in academic career
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5
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5
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To get skills to work in interdisciplinary teams.
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5
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6
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To get skills for solving and evaluating a problem
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4
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7
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Must be able to evaluate quality process and develop managing plans.
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5
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8
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To have knowledge about entrepreneurship and innovation issues.
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4
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9
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To reach the actual scientific knowledge by using communication and computer technologies.
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4
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10
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To transfer the knowledge about agriculture and life sciences by using modern techniques and equipment
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4
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11
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To have advanced oral and written communication skills
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5
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12
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To communicate and follow literature about agriculture and nature sciences by using a foreign language.
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-
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13
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To behave professionally and obey ethic values about vocational issues.
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5
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14
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To gain awareness and ability on environment and natural resources protection and to inform the public on these issues
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5
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