• View the Talks
• 34 min
  1. Principles of SOPs and hierarchy of documents

  • Dr. Laura Brown
• 38 min
  2. Effective SOP writing

  • Dr. Laura Brown
• 47 min
  3. Using process mapping, forms and templates for the production of SOPs

  • Mr. Gareth Turner
• 41 min
  4. Electronic SOPs vs. paper - compliance with FDA CFR 21 part 11

  • Mr. Gareth Turner
• 43 min
  5. Use of technology and document management systems for SOPs

  • Mr. Gareth Turner
• 29 min
  6. SOPs and improving business performance to meet GXP

  • Mr. Richard Winning
• 33 min
  7. Procedural assessments of SOPs to ensure SOPs are logical and meet GXP requirements

  • Mrs. Susan Ollier
  • Mrs. Pam Wilson
• 39 min
  8. SOPs and outsourcing

  • Dr. Laura Brown
• 27 min
  9. SOP training

  • Dr. Laura Brown
• 30 min
  10. SOPs as part of a quality centric process system

  • Dr. Laura Brown
• 18 min
  11. SOPs as part of the quality system

  • Mr. Steve Nicholas

Printable Handouts

PDF

Navigable Slide Index

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.