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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
- Roles and responsibilities
- Defining the responsibilities of each person
- Sponsor responsibilities
- Sponsors must understand GLP requirements
- Sponsor responsibilities when providing a test item
- Sponsor responsibilities - study plan, final report
- Sponsors - storage/retention of records/materials
- Sponsors - submitting a regulatory file
- Management responsibilities (1)
- Management responsibilities (2)
- Study director responsibilities (1)
- Study director responsibilities (2)
- Study director responsibilities (3)
- Study director responsibilities (4)
- Principal investigator responsibilities
- Archivist responsibilities
- Quality assurance
- Documenting roles and responsibilities
- Organisation chart
- Organisation chart example
- Personnel must have
- Curriculum vitae (CV)
- CV - recommendations
- Job descriptions
- Job descriptions - recommendations
- Training records (1)
- Training records (2)
- Archive records
- Acknowledgment
Topics Covered
- Responsibilities of Sponsors, Management, Study directors, Principal investigators, Archivists
- Storage/Retention of records/materials
- Quality assurance
- Documenting roles and responsibilities
- Organisation chart
- Curriculum vitae
- Job descriptions
- Training & Archive records
Talk Citation
Long, D. (2012, March 1). Good laboratory practice: roles and responsibilities [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved March 29, 2024, from https://hstalks.com/bs/2248/.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.