• 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. Speakers' background
3. Outline of the talk
4. Using technology or EDMS for SOPs
5. In days gone by
6. Moving with the times
7. Does paper have a place?
8. Does technology have a place?
9. What will an EDMS solution do for me?
10. Is the paper SOP dead?
11. A basic EDMS (1)
12. A basic EDMS (2)
13. Why then invest in technology?
14. What to expect from your EDMS
15. Meta data
16. Document versioning
17. Collaborative creation
18. Work flow
19. Document publishing
20. Document security
21. Electronic signatures
22. EDMS for SOPs (summary)
23. Linking documents
24. Linked documents (examples)
25. The SOP example with detail added
26. Guidance for associated documents
27. Linked documents in more detail
28. Forms and templates
29. Using a bridging document
30. Example of a bridging document
31. A thought for the future
32. Summary

Topics Covered

• Using technology or EDMS for SOPs
• The place of paper and of technology
• A basic EDMS
• What to expect from your EDMS
• Meta data
• Document versioning, publishing & security
• Collaborative creation
• Work flow
• Electronic signatures
• Linking documents
• Guidance for associated documents
• Forms & templates
• Using a bridging document
• Thoughts for the future

Links

Series:

• SOPs for Regulatory Applications for the Pharmaceutical Industry

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on June 13, 2013

Financial Disclosures

• Mr. Gareth Turner has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.