GLP – Good Laboratory Practice training

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

 

 

 

 

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