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GMP1: Introduction to GMP

Description: GMP: 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
HISTORY
1. What you will learn?
2. Outcomes
3. GMP history I
4. GMP history II
5. GMP history III
6. GMP history IV
7. USA
8. Australia
9. UK
10. Review

PRODUCT QUALITY
11. Product quality
12. What is quality-definition
13. Review I
14. Review II

MANAGING FOR QUALITY
15. Managing for Quality
16. Quality management
SCOPE OF GMP CODE I
17. What is GMP
18. Quality control
19. Self-inspection
20. GMP compliance
21. Personnel and training
22. Equipment
23. Premises and grounds
24. Review I

SCOPE OF GMP CODE II
25. Housekeeping
26. Cleaning and sanitation
27. Personal hygiene I
28. Personal hygiene II
29. Review II

SCOPE OF GMP CODE III
30. Documentation
31. Manufacturing records
32. Documentation I
33. Documentation II
34. Production controls
35. Manufacturing controls
36. Review III

CONCLUSION
37. Summary I
38. Summary II


COURSE OBJECTIVES
Students completing this course should be able to:
  • State the purpose of the Guide to GMP
  • State the four key product quality attributes
  • State the GMP requirements for personal hygiene
  • Describe the correct way to complete GMP records
  • List the essential production and packaging controls

 

   

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