Bonnes pratiques de laboratoire (BPL) Entraînement
– L'histoire & Purpose of GLP
What is GLP?
Organisation du centre d’essai & Personnel
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
Installations
Test system facilities
Facilities for handling test & reference items
Archive facilities
Waste disposal
Appareil, Matériaux & Reagents
General requirements
Computerised system validation
Systèmes de tests
Physical/chemical test systems
Test & Reference Items
Reserve samples
Procédures d'utilisation normalisées
Expected coverage
Performance de l'étude
Content of the study plan
Amendments
Deviations
Rapport des résultats de l'étude
Content of the final report
Stockage & Conservation des dossiers & Matériaux
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
Commanditaires
Multi-site studies
In-vitro studies
GLP Programmes
