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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
- Planning
- Prescriptive documents
- Examples of prescriptive documents
- Study plan
- Pivotal document
- GLP requirements for contents - study director
- GLP requirements for contents - proposed dates
- GLP requirements for contents - useful dates
- Approval / review of the study plan
- Amendments to the study plan
- GLP requirements for amendments
- Master schedule definition
- Regulatory inspectors' requests
- Master schedule list
- List necessity (1)
- List necessity (2)
- List necessity (3)
- Compiling the master schedule
- Archiving master schedule
- Recording
- Descriptive documents definition
- Examples of descriptive documents
- Raw data: definition
- Before data recording
- During data recording
- Data should show "What"
- Data should show "How"
- Data should show "When"
- Data should show "Who"
- ALCOA (1)
- ALCOA (2)
- ALCOA (3)
- Data management
- Sample form
- Carousel loading
- Data audit trail
- Archives
- What should be retained in an archive?
- Source of data generated
- Retaining data in the archive
- Associated documentation
- Study related documentation
- Environmental data
- Concentric series
- Archive function (1)
- Archive function (2)
- Archive function (3)
- Designated manager
- Movement of material into the archive
- Archives submission form
- Occasional retrieval of material
- History of document
- Retrieval (1)
- Retrieval (2)
- SOP - security
- Conditions which minimise deterioration
- Archive indexing
- Electronic archiving
- Archive duration (1)
- A reminder of data retained
- Archive duration (2)
- Data type and archive duration
- Licence for sale and archive duration
- Some potential difficulties in archiving
- Discarding archived data
- Acknowledgements and thanks
Topics Covered
- Prescriptive documents
- Study plan
- Pivotal document
- GLP requirements for contents and amendments
- Master schedule
- Regulatory inspectors' requests
- Descriptive documents
- Raw data
- Before and during data recording
- ALCOA
- Data management
- Carousel loading
- Data audit trail
- Source of data generated
- Retaining data in the archive
- Associated documentation
- Environmental data
- Concentric series
- Archive function
- Designated manager
- Movement of material into the archive
- Retrieval of material
- History of document
- SOP-security
- Conditions which minimise deterioration
- Archive indexing
- Electronic archiving
- Data type / Licence for sale and archive duration
- Difficulties in archiving
- Discarding archived data
Talk Citation
Withers, P. (2013, September 22). GLP: planning, recording, and archiving [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 25, 2024, from https://hstalks.com/bs/2635/.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Phil Withers has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.