Buone pratiche di laboratorio (GPL) Formazione
– La storia & Purpose of GLP
What is GLP?
Organizzazione delle strutture di prova & Personale
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
Strutture
Test system facilities
Facilities for handling test & reference items
Archive facilities
Waste disposal
Apparato, Materiali & Reagents
General requirements
Computerised system validation
Sistemi di prova
Physical/chemical test systems
Test & Reference Items
Reserve samples
Procedure operative standard
Expected coverage
Esecuzione dello studio
Content of the study plan
Amendments
Deviations
Reporting dei risultati dello studio
Content of the final report
Magazzinaggio & Conservazione dei registri & Materiali
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
Sponsor
Multi-site studies
In-vitro studies
GLP Programmes
