Description
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
