COURSE OUTLINE
INTRODUCTION
1. Welcome
2. Overview
3. Guidance documents
4. Assessment
THE LABORATORY QUALITY MANUAL
5. Introduction
6. Explaining ISO 17025
7. Quality manual overview
8. Quality system elements
9. Understanding the manual
10. Important SOPs
11. Personnel
12. Review
BASIC LABORATORY SAFETY PRACTICES
13. Introduction
14. Hazardous situations
15. Dangerous chemicals
16. MSDS
17. Who are MSDSs for?
18. Basic rules for lab safety
19. Review
RELATIONSHIPS BETWEEN LABORATORY DOCUMENTS
20. Introduction
21. Typical sample flow
22. Lab documentation
23. Documentation links
24. Test method structure
25. Specifications
26. Lab notebooks
27. Validation protocols
28. Performance parameters
29. Lab instruments
30. Change control
31. Review
RECORD KEEPING AND DATA RECORDING
32. Introduction
33. Importance of records
34. Key supporting records
35. Completing lab notebooks
36. Summarising records
37. Reviewing records
38. Record retention
39. Activity I
40. Activity II
41. Review
TEST METHODS AND SPECIFICATIONS
42. Introduction
43. Reference standards
44. Typical test methods
45. Importance of following methods
46. Specifications
47. Pharmacopoeias
48. Review
HOUSEKEEPING AND AUDITS
49. Introduction
50. Safety and efficiency
51. Housekeeping rules
52. Role of auditing
53. Audits and preparation
54. Review
CONCLUSION
55. Summary
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COURSE OBJECTIVES
Students completing this course should be able to:
- List typical chapters of a Laboratory Quality Manual
- State some basic laboratory safety practices
- Describe the linkage between various laboratory documents
- State the "rules" for record keeping and data recording
- List the key features of test methods and specifications
- State why GLP houskeeping is important
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