Printable Handouts

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Navigable Slide Index

1. Introduction
2. Questions to be answered
3. GLP
4. GLP as a quality assurance system
5. OECD GLP principles (1)
6. OECD GLP principles (2)
7. OECD GLP principles (3)
8. Quality assurance program implementation
9. Independent monitoring
10. Pre-arranged programme of audits/inspections
11. Audits must be conducted by competent persons
12. Audit findings must be recorded/documented
13. Study directors must respond to the audit findings
14. Typical QA inspection report
15. QA personnel
16. QA audits/inspections types
17. Study-based inspections
18. Facility/systems-based inspections
19. Process-based inspections
20. QA responsibilities
21. QA statement
22. 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

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on April 9, 2012

Financial Disclosures

• Mr. David Long has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.