Should there be a SME (Subject Matter Expert) for each element?

SGquality

Quite Involved in Discussions
#1
My question refers to Pharmaceuticals where I am not aware of the requirements - is it true that in a Pharma organization, the trainer should be like a Subject Matter Expert (SME) for that particular quality system element ?

My understanding was that a procedural training could be imparted to staff by our department trainer but one of my newly joined colleague from Pharmaceuticals mentioned that we need to have different SME Trainers for that respective quality system element. I have never heard of this requirement not did I find anything in 21 CFR Part 211.

Could you pls advise ?

:thanx:
 
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yodon

Staff member
Super Moderator
#3
Re: Should there be a SME for each element ?

Back in high school, sports (especially US football) were king. Coaches were kind of at the top echelon of the teaching ranks but they weren't subject matter experts in anything except sports. But since they were in the upper ranks, the school board essentially required them to contribute to teaching. Presumably, in order to minimize the impact of non-subject matter experts teaching, they generally taught history. Those were the WORST classes and nobody really learned anything. We ended up doing things like memorizing dates and places but never delved into the motivations behind events or the ramifications of the results of events.

So to answer your question, the regulations require that personnel are competent to do their job. If rote recitation of powerpoint slides sufficiently trains employees (and there are probably cases for this) then you could argue a subject matter is not needed. If, though, you are training on operating a particularly complex machine, then having a non-SME would probably be like my history teachers. They could deliver the material but the RESULTS from training would likely not be a trainee sufficiently competent to perform the tasks for which they are being trained. You need to decide the level of expertise required.
 
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