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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.
