Description
An introduction to the roles of QA and QC in the effective and safe production and control of medicinal products.
Course Objectives
Students completing this course should be able to:
- Recognize how attention to manufacturing a quality product reflects on day-to-day operations
- Identify the role of QA in pharmaceutical manufacturing
- Recognize how companies use GMP rules to minimize errors in manufacturing
- Identify the main roles and responsibility of QC
- Recognize the key elements of a pharmaceutical quality system
Course Outline
INTRODUCTION
1. Welcome
2. Outcomes
3. Reviews and assessments
4. PQS overview
QUALITY PRINCIPLES
5. What do you think?
6. GMP solution
7. What is quality?
8. Protecting consumers
9. Responsibility for quality
10. Knowledge and GMP behavior
11. GMP compliance program
QUALITY ASSURANCE
12. What do you think?
13. GMP solution
14. Overview
15. Traceability
16. Documents and records
17. Training
18. Internal audits
19. Effective audits
20. Corrective action
21. Vendor assurance
22. Change management
23. Release for supply
24. Review
GMP
25. What do you think?
26. GMP solution
27. Overview
28. Scope of GMP rules
29. GMP & documentation
30. Essential requirements
31. Why validate?
32. What needs validating?
33. GMP and process control
34. Process deviations
35. Contamination control
36. GMP rules and cleaning
37. Review
QUALITY CONTROL
38. What do you think?
39. GMP solution
40. Overview
41. Role of the laboratory
42. G(Control)LP
43. Lab documentation
44. Specifications
45. Sampling
46. The sampling game
47. Sampling limitations
48. Altering records
49. Review
PHARMACEUTICAL QUALITY SYSTEM (PQS)
50. ICH Q10 Guidance
51. PQS key elements
52. Management responsibility
53. CAPA systems
54. CAPA processes
CONCLUSION
55. Summary