良好实验室规范 (良好实验室规范) 训练
– 历史 & Purpose of GLP
What is GLP?
测试设施组织 & 人员
Management responsibilities
Study Director responsibilities
Principal Investigator responsibilities
Study Personnel responsibilities
Study plans, SOPs and the master schedule
检查
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, Materials & Reagents
General requirements
Computerised system validation
Test Systems
Physical/chemical test systems
Test & Reference Items
Reserve samples
标准操作程序
Expected coverage
Performance of the Study
Content of the study plan
Amendments
Deviations
Reporting of Study Results
Content of the final report
贮存 & Retention of Records & Materials
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
