Buenas prácticas de laboratorio (BPL) Capacitación
– La historia & Purpose of GLP
What is GLP?
Organización del centro de pruebas & Personal
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
Facilities
Test system facilities
Facilities for handling test & reference items
Archive facilities
Waste disposal
Apparatus, Materiales & Reagents
General requirements
Computerised system validation
Test Systems
Physical/chemical test systems
Test & Reference Items
Reserve samples
Estándar de Procedimientos Operativos
Expected coverage
Realización del estudio
Content of the study plan
Amendments
Deviations
Informe de los resultados del estudio
Content of the final report
Almacenamiento & Retención de registros & Materiales
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
Patrocinadores
Multi-site studies
In-vitro studies
GLP Programmes
