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- The OECD Principles of GLP
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2. Scope and application
- Mr. David Long
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3. Performing test systems and test items
- Prof. Sergio Caroli
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4. Why OECD GLP and not ISO / IEC 17025?
- Dr. Helen Liddy
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5. Principles of GLP
- Mr. David Long
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6. Performing: standard operating procedures
- Mrs. Katariina Rautalahti
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7. GLP: planning, recording, and archiving
- Mr. Phil Withers
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8. Reporting of study results
- Mr. Hedwig Beernaert
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9. Quality assurance
- Mr. David Long
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10. Facilities: buildings and equipment
- Mr. Hedwig Beernaert
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11. Multi-site studies and field studies
- Dr. Geetha Rajashekhar
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12. In vitro studies and short term studies
- Prof. Sergio Caroli
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13. Computers in a GLP environment
- Mr. John McNamee
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14. The application of the GLP principles in analytical chemistry
- Prof. Sergio Caroli
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15. Good laboratory practice: roles and responsibilities
- Mr. David Long
- Monitoring GLP Compliance
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16. Monitoring GLP compliance: history and OECD framework
- Mr. Richard Sigman
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18. Inspection procedures
- Mr. Theo Helder
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20. GLP in the European Union
- Mr. Maik Schmahl
- International Data Acceptance Through OECD
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22. International data acceptance through OECD: history and OECD context
- Mr. Richard Sigman
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24. Participation of non-OECD economies in the MAD system
- Ms. Christinah Leballo
Printable Handouts
Navigable Slide Index
- Introduction
- Questions to be answered
- GLP
- GLP as a quality assurance system
- OECD GLP principles (1)
- OECD GLP principles (2)
- OECD GLP principles (3)
- Quality assurance program implementation
- Independent monitoring
- Pre-arranged programme of audits/inspections
- Audits must be conducted by competent persons
- Audit findings must be recorded/documented
- Study directors must respond to the audit findings
- Typical QA inspection report
- QA personnel
- QA audits/inspections types
- Study-based inspections
- Facility/systems-based inspections
- Process-based inspections
- QA responsibilities
- QA statement
- Acknowledgements and thanks
Topics Covered
- GLP as a quality assurance system
- OECD GLP principles
- Quality assurance program implementation
- Independent monitoring
- Programme of audits/inspections
- Audit personnel Recording and documentation
- Study director audit responsibilities
- Typical QA inspection report
- QA personnel
- QA audits/inspections types
- QA statement
- QA responsibilities
Talk Citation
Long, D. (2012, April 9). Quality assurance [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 23, 2024, from https://hstalks.com/bs/2244/.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. David Long has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.