Good Laboratory Practices (GLP) Training
– The History & Purpose of GLP
What is GLP?
Test Facility Organisation & 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
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
Standard Operating Procedures
Expected coverage
Performance of the Study
Content of the study plan
Amendments
Deviations
Reporting of Study Results
Content of the final report
Storage & 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
Interested in learning whether current clinical programs, research developments, or emerging therapeutic approaches may be relevant to your situation?
Educational and research information only. Individual medical decisions should be made in consultation with qualified healthcare professionals.
