Good Laboratory Practices (BPL) Training
– The History & Purpose of GLP
What is GLP?
Test Facility Organisation & Pessoal
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
Instalações
Test system facilities
Facilities for handling test & reference items
Archive facilities
Waste disposal
Aparelho, Materiais & Reagents
General requirements
Computerised system validation
Sistemas de teste
Physical/chemical test systems
Test & Reference Items
Reserve samples
Procedimentos Operacionais Padrão
Expected coverage
Desempenho do Estudo
Content of the study plan
Amendments
Deviations
Relatório dos resultados do estudo
Content of the final report
Armazenar & Retenção de Registros & Materiais
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
Sponsors
Multi-site studies
In-vitro studies
GLP Programmes
