Printable Handouts

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Navigable Slide Index

1. Introduction
2. Overview
3. Objective of study audits
4. Purpose of study audits
5. Why are we auditing?
6. Who are we auditing for?
7. Primary purpose
8. How to select studies
9. Performing study audits (1)
10. The facility and the inspectors
11. Approach variation
12. What is examined will vary
13. Review question and listen
14. Traceability and reproducibility
15. Traceability
16. Reproducibility (1)
17. Reproducibility (2)
18. Reproducibility (3)
19. Checklist
20. If you think there is a problem - think again
21. If you think there is a problem - ask
22. If you think there is a problem - investigate
23. Auditors must be alert and observant creatures
24. Attitudes and behaviours (1)
25. Stick to the principles
26. Attitudes and behaviours (2)
27. Inspectors should be
28. The dirty dozen
29. Time wasters
30. Alarm bells
31. Reporting
32. The report should describe (1)
33. The report should describe (2)
34. Clearly state departures from the GLP principles
35. Summary
36. Acknowledgments

Topics Covered

• Objective and purpose of study audits
• How to select studies
• Performing study audits
• The facility and the inspectors
• Approach variation
• Review question and listen
• Traceability and reproducibility
• Checklist
• Thinking, asking & investigating problems
• Auditors & Inspectors
• Attitudes and behaviours
• Reporting
• Departures from the GLP principles

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Calder, L. (2012, March 1). OECD guidance for national compliance monitoring programmes: carrying out study audits [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved November 21, 2024, from https://doi.org/10.69645/ELCH7898.
Export Citation (RIS)

Publication History

• Published on March 1, 2012

Financial Disclosures

• Ms. Louise Calder, Other: I am employed by NATA, the Australian GLP compliance monitoring authority (CMA). NATA runs training courses for which people pay, but l am not involved directly with these courses. These courses are for facilities seeking GLP recognition. I also have participated in the training courses for GLP inspectors organised by the OECD Working Group on GLP.