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Printable Handouts
Navigable Slide Index
- Introduction
- Presenter biography
- Objectives
- What are SOPs? (1)
- SOPs ICH (1)
- SOPs ICH (2)
- What are SOPs? (2)
- How to write SOPs
- 5 Key points to principles for writing SOPs
- Why are SOPs important?
- Most common difficulties involved with SOPs
- Difference between SOPs and guidelines
- SOPs in large companies
- SOPs are reconstruction of events
- SOPs vs. guidelines
- Working documents
- When and why are SOPs needed?
- What are SOPs for?
- Reasons for having SOPs
- Before writing SOPs
- SOP Principles on format and layout of SOPs
- SOP content/structure: front page
- The SOP content (1)
- The SOP content (2)
- Other general structure considerations
- SOP control
- Suggestions for use: commitment
- Conclusion
- Copyright of presentation
Topics Covered
- What are SOPs?
- SOPs ICH
- How to write SOPs
- Why are SOPs important?
- Most common difficulties involved with SOPs
- Difference between SOPs and guidelines
- SOPs in large companies
- Working documents
- When and why are SOPs needed?
- SOP principles on format and layout of SOPs
- SOP control
Links
Series:
Categories:
Talk Citation
Brown, L. (2013, June 13). Principles of SOPs and hierarchy of documents [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved August 17, 2024, from https://doi.org/10.69645/JYLH7344.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Laura Brown, Consultant: LB Training & Development Ltd.
A selection of talks on Methods
Transcript
Please wait while the transcript is being prepared...
0:00
My name is Dr. Laura Brown.
I'm going to tell you about the principles of standard operating procedures and also focus on some of the aspects of some hierarchies of the documents as well.
0:13
Just to give you a little bit of information about myself.
My name is Dr. Laura Brown.
I work as a course director on two pharmaceutical industry, MSc courses, one in Clinical Research, and one in Regulatory Affairs.
The rest of the time I work as a quality assurance and training consultant within the pharmaceutical industry.
Prior to that, in terms of qualifications, I have a number of degrees and also further qualifications in the pharmaceutical industry.
I also have PhD and MBA.
My experience spans working for a number of pharmaceutical companies,
and also I've written a number of publications about processes such as project management, and my work has involved clinical research.
And in terms of standard operating procedures,
I regularly present courses on standard operating procedures and how to write them,
and also write SOPs and review SOPs for a variety of different companies in the pharmaceutical industry,
including start-up companies as well that don't have procedures in place.
1:16
The objectives of this first session is very much to give you an overview of what we're going to be covering in the whole of the programme and to set the scene.
The objectives are really to understand some key principles of SOPs.
You know why we have them, the benefits are etc.
And often these days a hierarchy of documents that we have available to us.
But really, in terms of inspector's requirements they're potentially looking for some additional documents.
And also it's very helpful for organisations to have policy documents, and other documents which are somewhat less regimented than the SOPs to give more flexibility.
And I'll also go through some basic principles relating to suggestions for format and structure.
And finally, touching on some aspects of use, as I'm sure probably most of you are aware,
it's all very well having SOPs, but what's really important is actually people use them.