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VAL 4: Operational and Performance Qualification
Description: An introduction to Operational (OQ) and Performance Qualification (PQ).
Price: $259 (AUD)
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(Australian customers, please add GST.)
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Terms and conditions
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COURSE OUTLINE
INTRODUCTION TO OQ/PQ
1. Introduction
2. Outcomes
3. First Class Pharmaceuticals
4. Meet the V Team
5. The new line
6. Definitions
OQ PHASE
7. The scope of OQ
8. OQ responsibilities
9. Typical responsibilities of the vendor
10. Definitions
11. Protocol design considerations
12. OQ activities
13. OQ tests
14. Test requirements
15. Executing the protocol
16. Final OQ report
17. Review
PQ PHASE
18.
The scope of PQ
19. PQ responsibilities
20. PQ steps
21. PQ activities
22. Microbial monitoring
23. Other considerations
24. Executing PQ I
25. Executing PQ II
26. OQ/PQ comparison
27. Documentation requirements
28. Final PQ report
29. Review
Conclusion
30. Summary
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COURSE OBJECTIVES
Students completing this course should be able to:
- Define OQ and PQ scope
- Identify and explain the scope of OQ and PQ
- Identify and explain the activities to be carried out during OQ and PQ
- Identify and explain the responsibilities of OQ and PQ
- Summarise the key differences between OQ and PQ
- Prepare, approve, and execute an OQ protocol
- Compile an OQ and a PQ report
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SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.
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