İyi Laboratuvar Uygulamaları (GLP) Eğitim
– Tarih & Purpose of GLP
What is GLP?
Test Tesisi Organizasyonu & Personel
Management responsibilities
Study Director responsibilities
Principal Investigator responsibilities
Study Personnel responsibilities
Study plans, SOPs and the master schedule
Inspections
Final reports
Reporting QA findings
The QA statement
Test facility & test site QA differences
Tesisler
Test system facilities
Facilities for handling test & reference items
Archive facilities
Waste disposal
Aparat, Malzemeler & Reagents
General requirements
Computerised system validation
Test Sistemleri
Physical/chemical test systems
Test & Reference Items
Reserve samples
Standart çalışma prosedürleri
Expected coverage
Çalışmanın Performansı
Content of the study plan
Amendments
Deviations
Çalışma Sonuçlarının Raporlanması
Content of the final report
Depolamak & Kayıtların Saklanması & Malzemeler
Retention periods
Submission to the archive
Retention
Disposal & transfer
Additional OECD GLP Consensus/Advisory Documents & Position Papers
Suppliers
Field studies
Short-term studies
Computer systems
Sponsorlar
Multi-site studies
In-vitro studies
GLP Programmes
