Information Package / Course Catalogue
| Course Code | : VET245 |
| Course Type | : Area Elective |
| Couse Group | : First Cycle (Bachelor's Degree) |
| Education Language | : Turkish |
| Work Placement | : N/A |
| Theory | : 1 |
| Prt. | : 1 |
| Credit | : 2 |
| Lab | : 0 |
| ECTS | : 3 |
This course is designed to improve knowledge and understanding of the requirements of GLP regulations. To make the GLP regulations applied in an efffective way and to assess the current conditon of GLP is among the objectives of this course.
This course focuses on the requirements of the Good Laboratory Practice (GLP) regulations imposed by the Food and Drug Administration (FDA). These regulations will be compared and contrasted to international rules for GLP studies (predominantly OECD regulations). This interactive presentation encompasses facility and equipment requirements, documentation requirements, roles and responsibilities, plus outsourcing relationships. Practical real world examples are used to emphasize key aspects of the regulations.
| Assoc. Prof. Bahattin Taylan KOÇ |
| Prof. Mehmet Tolga TAN |
| Prof. Nural EROL |
| 1. | To be able to know laboratory operating principles, hazards and precautions. |
| 2. | To be able to know how to maintain himself / herself and his / her environment from laboratory hazards and accidents and how to do first aid. |
| 3. | To be able to understand the principles of GLP and its regulatory basis |
| 4. | To be able to understand the responsibility of key stakeholders and unit operations, such as the Study Director, |
| 5. | To be able to understand the requirements of a laboratory facility |
| 6. | To be able to understand the QA programme documentations, such as Standard Operating Procedures, protocols, study plans, data quality and integrity, auditing, archival, etc. |
| 7. | To be able to understand the regulatory inspections |
| 1. | Good Laboratory Practice (Second Edition) Yazar(lar) : Jürg P. Seiler Springer, 2005. |
| 2. | Good Laboratory Practice Regulation (Fourth Edition) Yazar(lar) : Sandy Weinberg Informa Healthcare, 2007. |
| Type of Assessment | Count | Percent |
|---|---|---|
| Midterm Examination | 1 | %40 |
| Final Examination | 1 | %60 |
| Activities | Count | Preparation | Time | Total Work Load (hours) |
|---|---|---|---|---|
| Lecture - Theory | 14 | 0 | 1 | 14 |
| Lecture - Practice | 14 | 1 | 1 | 28 |
| Assignment | 1 | 5 | 0 | 5 |
| Laboratory | 1 | 2 | 1 | 3 |
| Midterm Examination | 1 | 10 | 1 | 11 |
| Final Examination | 1 | 18 | 1 | 19 |
| TOTAL WORKLOAD (hours) | 80 | |||
PÇ-1 | PÇ-2 | PÇ-3 | PÇ-4 | PÇ-5 | PÇ-6 | PÇ-7 | PÇ-8 | PÇ-9 | PÇ-10 | PÇ-11 | PÇ-12 | PÇ-13 | PÇ-14 | PÇ-15 | PÇ-16 | PÇ-17 | PÇ-18 | PÇ-19 | PÇ-20 | PÇ-21 | PÇ-22 | PÇ-23 | PÇ-24 | PÇ-25 | PÇ-26 | PÇ-27 | PÇ-28 | PÇ-29 | PÇ-30 | PÇ-31 | PÇ-32 | PÇ-33 | PÇ-34 | PÇ-35 | PÇ-36 | |
OÇ-1 | 2 | 2 | 4 | 2 | ||||||||||||||||||||||||||||||||
OÇ-2 | 1 | |||||||||||||||||||||||||||||||||||
OÇ-3 | ||||||||||||||||||||||||||||||||||||
OÇ-4 | ||||||||||||||||||||||||||||||||||||
OÇ-5 | ||||||||||||||||||||||||||||||||||||
OÇ-6 | ||||||||||||||||||||||||||||||||||||
OÇ-7 | ||||||||||||||||||||||||||||||||||||