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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
- Definitions: GLP compliance monitoring
- Definitions: national GLP compliance programme
- OECD decision-recommendation C(89)87 (final)
- Revised guidance for good laboratory practice
- Revised guidance for laboratory inspections
- GLP compliance recognition in member countries
- Conditions member parties must comply with
- Annex III to OECD council decision
- Main points of annex III (1)
- Main points of annex III (2)
- Main points of annex III (3)
- OECD
- OECD MAD program
- Scope of the GLP principles
- Monitoring authorities I
- Monitoring authorities II
- Monitoring authorities III
- Monitoring authorities IV
- Main differences
- 3 levels of authorities
- Example: the Netherlands
- GLP compliance monitoring in the Netherlands
- GLP organisation in Germany
- USA, medicinal products
- Korea
- Japan: 7 programmes
- Monitoring programme administration
- Keeping confidentiality
- Confidentiality
- Personnel employment and training
- The inspector
- Strictly governmental monitoring authorities
- Outsourced to an accreditation body
- Partly governmental, partly accreditation bodies
- (National) GLP compliance programme
- How to enter a programme
- Fees
Topics Covered
- Compliance monitoring
- Inspection of companies and laboratories
- Assessing their adherence to the OECD Principles of Good Laboratory Practice
Talk Citation
Helder, T. (2012, March 12). Compliance monitoring systems and organization around the world [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved March 29, 2024, from https://hstalks.com/bs/2250/.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Theo Helder has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Compliance monitoring systems and organization around the world
Published on March 12, 2012
35 min