Description
An introduction to control and management of manufacturing and quality control testing of pharmaceutical products
Course Objectives
Students completing this course should be able to:
- Explain why your company has implemented GMP
- State the purpose of GMP regulations and codes of 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
Course Outline
INTRODUCTION
1. Welcome
2. Objectives
3. Reviews and assessments
4. What do you think?
5. GMP solution
6. Events that have shaped GMP
7. Evolution of GMP
8. The introduction of codes of GMP
9. Regulatory agencies around the world
10. FDA, MHRA/EMEA, TGA
11. PIC/S
12. What does GXP mean?
13. Review
PRODUCT QUALITY
14. What do you think?
15. GMP solution
16. Overview
17. What is quality?
18. Protecting consumers with GMP rules
19. Quality management
20. Quality assurance
21. Quality control
22. Review
SCOPE OF GMP RULES
23. What do you think?
24. GMP solution
25. Scope of GMP codes
26. Self inspection/internal audits
27. GMP compliance program
28. Personnel & training
29. Equipment & GMP
30. Facility & grounds
31. Manufacturing & GMP
32. Manufacturing controls
33. Review
CLEANING & SANITATION
34. What do you think?
35. GMP solution
36. GMP & housekeeping
37. Cleaning & sanitation
38. Personal hygiene & GMP
39. Personal hygiene programs
40. Review
DOCUMENTATION
41. What do you think?
42. GMP solution
43. GMP and documentation
44. GMP & manufacturing records
45. Rules for completing records
46. Exercise
47. Review
CONCLUSION
48. Summary