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Printable Handouts
Navigable Slide Index
- Introduction
- Key objectives
- What is outsourcing in pharma
- Contract Research Organization (CRO)
- CRO industry (1)
- CRO GXP services all require SOPs
- CRO industry (2)
- Key driver of outsourcing
- Integrated CRO alliances
- Models of outsourcing
- What SOPs are needed by the sponsor?
- SOP: CRO selection (1)
- SOP: CRO selection (2)
- SOP: QA considerations
- SOP: audit of vendors
- CRO/third party vendor assessments
- Assessments/audits - CROs
- Delegation of authority to CRO
- SOP training
- Clarity is of the essence
- Considerations for CROs SOPs
- SOP CRO management
- 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:
Categories:
Talk Citation
Brown, L. (2013, June 13). SOPs and outsourcing [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 9, 2024, from https://doi.org/10.69645/FKBV1167.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Laura Brown, Consultant: LB Training & Development Ltd.