Effective SOP writing

Published on June 13, 2013   38 min

A selection of talks on Methods

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Hello, welcome again from Dr. Laura Brown. We're going to move into effective SOP writing now.
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.
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.
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: