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1. Introduction
2. Overview
3. Introduction of SOPs
4. Why do we need SOPs?
5. Regulatory requirements
6. Quality related terminology
7. Process capability
8. SOP as a trainee manual
9. The large volume of a paper-based system
10. Information on demand
11. FDA deficiencies
12. Traditional approach
13. Uniformity of performance (1)
14. SOP in a traditional quality system
15. SOP developed by function
16. Independent quality department
17. A process based approach (1)
18. A process based approach (2)
19. Modern, robust quality management system
20. DMAIC approach to continual improvement
21. Process mapping
22. Identification of gaps
23. Incorporation into the workflow
24. Mistake proofing
25. Poka yoke
26. FlyBy airlines
27. Online booking system
28. Dynamic form
29. Selecting a date for the flight
30. Flow of the processes
31. Uniformity of performance (2)
32. The advantages of the approach
33. Documentation of key processes
34. What software to use?
35. Conclusions
36. Change of paradigm
37. Do SOPs really fit the new generation?
38. Requirements of SOPs
39. Summary

Topics Covered

• The need for SOPs
• Requirements of SOPs
• Quality related terminology
• Process capability
• SOP as a trainee manual
• The large volume of a paper-based system
• Information on demand
• FDA deficiencies – A traditional vs. a process based approach
• Uniformity of performance
• SOP in a traditional quality system
• SOP developed by function
• Independent quality department
• Modern, robust quality management system
• DMAIC approach to continual improvement
• Process mapping
• Identification of gaps
• Incorporation into the workflow
• Mistake proofing (Poka yoke)
• FlyBy airlines and the online booking system example
• Flow of the processes
• Documentation of key processes – SOP software
• SOPs and the new generation

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