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1. Introduction
2. Key objectives
3. What is outsourcing in pharma
4. Contract Research Organization (CRO)
5. CRO industry (1)
6. CRO GXP services all require SOPs
7. CRO industry (2)
8. Key driver of outsourcing
9. Integrated CRO alliances
10. Models of outsourcing
11. What SOPs are needed by the sponsor?
12. SOP: CRO selection (1)
13. SOP: CRO selection (2)
14. SOP: QA considerations
15. SOP: audit of vendors
16. CRO/third party vendor assessments
17. Assessments/audits - CROs
18. Delegation of authority to CRO
19. SOP training
20. Clarity is of the essence
21. Considerations for CROs SOPs
22. SOP CRO management
23. Conclusion

Topics Covered

• What is outsourcing in pharma
• Contract Research Organization (CRO)
• CRO GXP services all require SOPs
• Key driver of outsourcing
• Models of outsourcing
• What SOPs are needed by the sponsor?
• SOP: CRO selection
• SOP: QA considerations
• SOP: audit of vendors
• CRO/third party vendor assessments
• Delegation of authority to CRO
• SOP training
• Considerations for CROs SOPs

Links

Series:

• SOPs for Regulatory Applications for the Pharmaceutical Industry

Categories:

• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on June 13, 2013

Financial Disclosures

• Dr. Laura Brown, Consultant: LB Training & Development Ltd.