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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
- Contents
- Principles of GLP
- Documents for compliance monitoring authorities
- Consensus documents (1)
- Consensus documents (2)
- Advisory documents
- OECD guidelines for the testing of chemicals
- Documents in GLP quality system
- Documents produced in each step of the study
- Definition of SOPs
- SOPs - what are they?
- What should be covered by SOPs?
- Why do we need SOPs? (1)
- Why do we need SOPs? (2)
- The SOP of SOPs
- Who writes SOPs?
- Roles of different personnel
- Role of QA with SOPs
- Role of management
- Who is management? (1)
- Who is management? (2)
- Role of study personnel
- Deviations from SOPs
- Storage of SOPs
- List of SOPs: test and reference items
- List of SOPs: apparatus and materials
- List of SOPs: computerised systems
- Record keeping, reporting, storage and retrieval
- List of SOPs: test system (1)
- List of SOPs: test system (2)
- List of SOPs: QA inspections covering
- SOPs from sponsors
- e-SOPs (1)
- e-SOPs (2)
- SOPs for field studies
- Multi-site situation?
- Multi-site: procedures described in SOPs
- Multi-site: test site SOPs
- Multi-site: if test facility SOPs used
- Multi-site: deviations
- Inspecting SOPs: at the starting conference
- Inspecting SOPs: the SOP of SOPs
- Inspecting SOPs: study deviations
- Inspecting SOPs: the laboratory area and QA
- Inspecting SOPs: inspect different roles of people
- Deviations sometimes observed
- References
Topics Covered
- Reasons for having SOPs
- Requirements needed for SOP systems to comply with OECD principles
- SOP requirements for sponsors
- e-SOPs
- Field Studies
- Multi-site studies
- How to inspect SOPs
Talk Citation
Rautalahti, K. (2012, March 1). Performing: standard operating procedures [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 20, 2024, from https://hstalks.com/bs/2242/.Export Citation (RIS)
Publication History
Financial Disclosures
- Mrs. Katariina Rautalahti has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.