SeerPharma Pty Ltd :: DISCover web-based training

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QC 1: Introduction to Quality Control

Description: This module introduces participants to the basic concepts and requirements of Good Quality Control Laboratory Practices. It will review industry standards used in specifying requirements for QC and define the elements in establishing a Laboratory Quality System and Quality Manual for a chemical analytical laboratory.

Price: $239 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

INTRODUCTION
1. Introduction
2. Quality System overview
3. Quality System elements
4. Understanding the manual
5. Important SOPs
6. Typical sample flow
7. Review

BASIC LABORATORY SAFETY PRACTICES
8. Introduction
9. Hazardous situations
10. Dangerous chemicals
11. MSDS
12. Who are MSDSs for?
13. Basic rules for lab safety
14. Review

RELATIONSHIPS BETWEEN LABORATORY DOCUMENTS
15. Introduction
16. Documentation links
17. Lab documentation
18. Test method structure
19. Specification
20. Lab notebooks
21. Validation protocols
22. Performance parameters
23. Lab instruments
24. Change control
25. Review

RECORD KEEPING AND DATA RECORDING
26. Introduction
27. Importance of records
28. Key supporting records
29. Completing lab notebooks
30. Summarising records
31. Reviewing records
32. Record retention
33. Application
34. Review

TEST METHODS AND SPECIFICATIONS
35. Introduction
36. Pharmacopoeias
37. Reference Standards
38. Typical test methods
39. Following methods
40. Specifications
41. Review

HOUSEKEEPING AND LAB AUDITS
42. Introduction
43. Safety and efficiency
44. Housekeeping rules
45. Role of auditing
46. Audits and preparation
47. Application
48. Review

CONCLUSION
49. Summary

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 QC housekeeping is important

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