|
|
| ECZ5039 | Good Laboratory Practices | 2+0+0 | ECTS:4 | | Year / Semester | Fall Semester | | Level of Course | Second Cycle | | Status | Elective | | Department | DEPARTMENT of PHARMACEUTICS | | Prerequisites and co-requisites | None | | Mode of Delivery | | | Contact Hours | 14 weeks - 2 hours of lectures per week | | Lecturer | Doç. Dr. Sercan YILDIRIM | | Co-Lecturer | | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | Informing students about the conditions and organizational processes under which non-clinical health and environmental safety work is planned, performed, monitored, recorded, archived and reported |
| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Have knowledge about improving the protection of human health and the environment, facilitating the international acceptance of test data, preventing the formation of technical trade barriers. | 2,10,13,14 | 1, | | LO - 2 : | Understand the effect of standardized procedures on test reliability and accuracy. | 2,10,13,14 | 1, | | LO - 3 : | Understands the importance of mutual acceptance of data in a globalizing world. | 2,10,13,14 | 1, | | LO - 4 : | Learns the organizational structure of the organizations within the scope of good laboratory practices and test execution procedures, document types and the duties and responsibilities of the personnel involved in the studies. | 2,10,13,14 | 1, | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), LO : Learning Outcome | | |
| In this course, the development of good laboratory practices (GLP) from the 1970s to the present day will be discussed. Information will be given about why GLP is necessary, its basic elements, the organizational and physical structure of GLP laboratories, the importance of GLP in the globalized world, how to carry out experimental procedures and the status of GLP in our country. |
| |
| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | Emergence and definition of good laboratory practice | | | Week 2 | Key elements of good laboratory practice | | | Week 3 | Resources in good laboratory practice: Organization - personnel | | | Week 4 | Study director and multi-site situation | | | Week 5 | Resources for good laboratory practice: Buildings and equipment | | | Week 6 | Characterization in good laboratory practice | | | Week 7 | Test items in good laboratory practice | | | Week 8 | Test systems in good laboratory practice | | | Week 9 | Midterm Exam | | | Week 10 | Rules for conducting studies | | | Week 11 | Standard operating procedures | | | Week 12 | Results: Raw data and data collection | | | Week 13 | Reporting the study | | | Week 14 | Compliance monitoring procedures in good laboratory practice | | | Week 15 | Good laboratory practices and quality assurance | | | Week 16 | Final Exam | | | |
| 1 | Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development -2nd ed. | | | 2 | Weinberg, S. (Ed.). (2007). Good Laboratory Practice Regulations (4th ed.). CRC Press. https://doi.org/10.3109/9780849375842 | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | 11/2024 | 1 | 50 | | End-of-term exam | 16 | 11/2025 | 1 | 50 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | Yüz yüze eğitim | 2 | 14 | 28 | | Arasınav için hazırlık | 5 | 7 | 35 | | Arasınav | 1 | 1 | 1 | | Dönem sonu sınavı için hazırlık | 6 | 7 | 42 | | Total work load | | | 106 |
|