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GMP9: Quality Assurance and Quality Control

Description: An introduction to control and management of manufacturing and quality control testing of pharmaceutical products.

Price: $209 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE
INTRODUCTION
1. Introduction
2. What you will learn
3. Outcomes
4. QA, GMP and QC

QUALITY CONTROL
5. Quality Control
6. QC sampling and testing
7. QC and specifications
8. Sampling plan procedure
9. Review I
10. Sampling limitations
11. Review II
12. GLP
13. Review III

GMP AND VALIDATION
14. GMP and validation
15. GMP requirements
16. What is GMP about?
17. What is validation?
18. Benefits of validation
19. What needs to be validated?
20. Environment
21. Personnel
22. Methods
23. Machines
24. Materials
25. Measurement
26. In-process control
27. Review

QUALITY ASSURANCE
28. Quality Assurance
29. GMP internal audit
30. Control over manufacturing changes
31. Vendor assurance
32. GMP & process deviation
33. Release for supply
34. Review

QUALITY PRINCIPLES
35. Quality principles I
36. Quality principles II
37. Importance of training
38. GMP training
39. Knowledge
40. Quality people & customers

SUMMARY
41. Summary I
42. Summary II
43. Summary III
44. Summary IV



COURSE OBJECTIVES
Students completing this course should be able to:
  • State the limitations of sampling and testing
  • State how QA, GMP, and QC are different but complementary
  • State the role of GMP auditing
  • State how you take responsibility for product quality

 

   

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