Reasons why knowledge is important in GMP and QMS
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Reasons why knowledge is important in GMP and QS
How I see it
 
 
If you buy a book shelf and put it together in accordance with the supplied “validated” instruction manual, it will most probably stand steady in your living room. But if you don´t bother to follow instructions, it may end up with a shelf being placed in the wrong direction, and if you then place an items on that shelf, it will perhaps fall apart.

It is the same way with your quality management system. You need your manual (your quality procedures) on how to manufacture your products. If you don’t follow these procedures or lack procedures, there is a high probability that something goes wrong in the production of your product. It may just cause a delay in the production process, but it can also cause worse things like quality problems and potential harm to the patient or user of your product. Another aspect may be criticism from authorities during inspections.
There are many examples where quality problems, both in production but also in other areas such as product design, handling or installation, has led to actual patient harm. The key to success is knowledge – with more knowledge about requirements - and why these requirements have to be followed – the less mistakes there will be.
The key to success is knowledge – with more knowledge about requirements – the less mistakes there will be.
 
It is my mission to share this knowledge with my customers. The knowledge may then be the basis for them to continue to develop and manufacture safe and effective products with the right quality.

That’s why Knowledge matters.
My big why
 
When I see in the eyes of a person attending one of my courses that I have inspired them to learn more about a specific topic, and to go back “home” and improve something in their quality system based on this knowledge – that is what makes me love my job!
Did you know?
 
One big trend of 2019, behavioural design and nudging, is very much applicable in Life Science industry and can help you to improve quality – here you can read more about the concept and theory behind this.

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Anna Lundén
Training director
 
How you can get it
 
 
In-house courses
 
If you don’t want to wait for next occasion of our course “Tools to decrease human errors , we can come to your site and run this course as an inhouse activity. We also have several other courses that we can adapt to your specific need about human behaviour and communication challenges!

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The Key2Compliance® team wish you all
Happy Holidays!


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from December 21st to January 7th