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Printable Handouts
Navigable Slide Index
- Introduction
- Presenter's biography
- Objectives
- The process of writing an SOP
- Key considerations for writing an SOP
- More considerations for writing an SOP
- Providing SOP flexibility
- Managing cultural differences
- Approaches for writing SOPs
- Who and how
- Additional considerations
- Effective SOP writing team - membership
- Effective SOP writing team - meetings
- Review draft
- Effective SOP writing team - review draft
- Effective SOP writing team - review draft (2)
- Editing
- Finalization
- Implementation
- Distribution and control
- Retrieval of SOPs
- Key considerations
- More writing considerations
- Good English style - active words
- Good English style - emphasizing information
- Good English style - KISS
- Good English style - additional tips
- Translating activities into SOPs
- Level of detail
- Level of detail - additional tips
- Conclusion
- Thank you
- Copyright of presentation
Topics Covered
- The process of writing an SOP
- Key considerations for writing an SOP
- Managing cultural differences
- Approaches for writing SOPs
- Effective SOP writing team
- Review draft
- Editing
- Finalization
- Implementation
- Distribution and control
- Retrieval of SOPs
- Good English style
- Translating activities into SOPs
- Level of detail
Links
Series:
Categories:
Talk Citation
Brown, L. (2013, June 13). Effective SOP writing [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 5, 2024, from https://doi.org/10.69645/ZNMO1667.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Laura Brown, Consultant: LB Training & Development Ltd.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello, welcome again from Dr. Laura Brown.
We're going to move into effective SOP writing now.
0:09
Just to give you a little bit about myself,
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 further qualifications in the pharmaceutical industry.
I also have a PhD and MBA.
My experience spans working for a number of pharaceutical companies
and also I've written a number of publications about processes such as project management and my work has involved clinical research.
In terms of standard operating procedures,I regularly present courses on standard operating procedures, 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.
1:10
What I'm going to be covering here is trying to go through a sort of common step by step process that is used by organisations to prepare SOPs.
Particularly, they tend to be within a sort of fairly large type of organisations process, but it can work equally well for smaller organisations.
I will also include some tips about how to try to ensure that the writing is effective.
1:36
So some key considerations which are typically thought through:
How am I going to write them?
Who's going to do it?
There may well be a team of people involved, maybe input from end users.
Maybe somebody's going to do editorial work, QA person, additional consultants, by giving advice on particular areas.
The review and editing process, finalisation, having the SOPs implemented and of course that distribution and control,
which in many companies is done electronically these days.
This is a typical process.
Key considerations: