
| Course Code | : BYL363 |
| Course Type | : Area Elective |
| Couse Group | : First Cycle (Bachelor's Degree) |
| Education Language | : Turkish |
| Work Placement | : N/A |
| Theory | : 2 |
| Prt. | : 1 |
| Credit | : 3 |
| Lab | : 0 |
| ECTS | : 4 |
This course aims to provide a comprehensive understanding and instruction of Laboratory Safety and Good Laboratory Practice (GLP) principles. It focuses on ensuring the effective implementation of GLP guidelines, while also enabling the evaluation and interpretation of current GLP standards.
This course is centered on the compliance requirements of GLP regulations enforced by the FDA. These rules will be compared against OECD guidelines and synthesized with international GLP practices.
| 1. | The student understands laboratory working principles, potential hazards, and the necessary safety precautions. |
| 2. | The student knows how to protect themselves and their surroundings from laboratory-related hazards and accidents and is familiar with basic first aid procedures. |
| 3. | Understands the principles of GLP (Good Laboratory Practice) and learns the fundamentals of its regulations. |
| 4. | Understands the organization of laboratory work and the allocation of responsibilities. |
| 5. | Understands the essential characteristics and requirements of a laboratory. |
| 6. | Acquires knowledge of the Quality Assurance (QA) Unit. |
| 7. | Understands the provisions and requirements of inspection procedures. |
| 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 |
|---|---|---|
| Attending Lectures | 1 | %5 |
| Verbal Examination | 1 | %5 |
| Midterm Examination | 1 | %30 |
| Final Examination | 1 | %60 |
| Activities | Count | Preparation | Time | Total Work Load (hours) |
|---|---|---|---|---|
| Lecture - Theory | 14 | 1 | 2 | 42 |
| Lecture - Practice | 6 | 1 | 1 | 12 |
| Midterm Examination | 1 | 18 | 2 | 20 |
| Final Examination | 1 | 20 | 2 | 22 |
| TOTAL WORKLOAD (hours) | 96 | |||
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 | |
OÇ-1 | 4 | 2 | 2 | 2 | 3 | ||||||||||
OÇ-2 | 4 | 2 | 3 | 3 | 1 | 2 | |||||||||
OÇ-3 | 4 | 3 | 2 | 4 | 3 | ||||||||||
OÇ-4 | 4 | 2 | 5 | 3 | 2 | ||||||||||
OÇ-5 | 5 | 3 | 4 | 3 | 4 | 1 | 1 | ||||||||
OÇ-6 | 5 | 3 | 3 | 2 | 4 | 1 | |||||||||
OÇ-7 | 4 | 4 | 3 | 4 | 4 | 2 | |||||||||