• 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. Introduction to SOPs
3. Overview
4. Process based SOPs
5. Conventional approach to SOPs
6. Process based approach
7. Process maps
8. Basic process map construction
9. Information added to a process
10. Process groups
11. ‘End-to-End’ map
12. Process structure benefits
13. Best practice
14. Maps in documents
15. Using enterprise architecture software
16. Enterprise architecture software
17. EA software benefits
18. Reports – Some examples
19. Example report from an EA application
20. Process modelling
21. Process flow: input / output analysis (1)
22. Process flow: input / output analysis (2)
23. Continuous improvement
24. Process optimisation model
25. Risk identification
26. Summary

Topics Covered

• The basics of process mapping for business use
• How process maps can be used to deliver useful and effective SOPs and procedural information
• How process maps can be linked in a hierarchical way to provide the basis of an organised SOP /procedural management system
• The importance and use of best practice standards to underpin process maps for SOPs
• The use of Enterprise Architecture applications to create and store process maps and to enable business analysis and process modelling

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. Richard Winning has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.