Description
This module is intended to provide an overview to cover the basics of infrastructure qualification both during implementation and the ongoing use of infrastructure.
Course Objectives
Students completing this course should be able to:
- Define the terminology of infrastructure qualification
- Identify which infrastructure needs to be qualified
- Explain the Infrastructure Qualification Lifecycle
- Identify qualification activities and documentation
- Identify post-qualification activities required to keep infrastructure in a qualified state
Course Outline
INFRASTRUCTURE QUALIFICATION
1. Introduction
2. First Class Pharmaceuticals
3. Initial Meeting
4. Meeting
5. What Is Quality?
6. Computerized Systems
7. Components
8. Scope of Qualification
9. Why Qualify?
10. Impact on the Industry
11. Control and Compliance I
12. Control and Compliance II
13. Summary
14. Review
WHAT AND HOW TO QUALIFY?
15. Introduction
16. What to Qualify?
17. What is Infrastructure?
18. The Big Picture
19. Platform Life Cycle
20. Activities and Documentation
21. Roles and Responsibilities
22. Good Documentation Practices
23. Review I
24. Summary
25. Review II
ONGOING CONTROL
26. Introduction
27. Operational Lifecycle
28. Review
CONCLUSION
29. Summary