A. Introduction to Preclinical Toxicology
1. Pharmaceutical products- Regulatory requirements and guidelines
2. Agrochemicals/Pesticides- Regulatory requirements and guidelines
B. Infrastructure
3. Animal/ in vivo facility - Design, utilities, equipment, animals, breeding/stock maintaining/husbandry 4. Procedure, studies, standard operating procedure and guideline for Animal/ in vivo facility
5. In vitro facility - Design, utilities, equipment, cell line maintaining procedure, studies, standard operating procedure and guideline
6. Maintenance and utility area for in vitro facility
7. Design, utilities, equipment maintenance and guidelines for in vitro facility C. Good laboratory practices (GLP) requirements
8. Test Facility Management 9. Responsibilities, qualification and training
10. Study Directors/Study personnel
11. Responsibilities, qualification and training
D. Test item control office (TICO)
12. Design, utilities, equipment maintenance and guideline
13. Responsibilities, qualification and training
E. Quality Assurance Unit (QAU)
14. Responsibilities, qualification and training
15. Archiving information 16. Design, utilities, equipment maintenance and guideline
17. Responsibilities, qualification and training
