Having been an auditee and an auditor, I have seen how difficult we can make it for the auditee.
My top 2 words of advice would be to BE KIND.
As an AUDITEE, we know that there are gaps in our processes and sometimes we are just not given the time or resource to have these resolved. My advic…
The below process flow shows how anyone (Subject Matter Expert), that is trained on the change control process, can raise a change within the organisation. The change management process to be followed can essentially be paper based or electronic however, both can follow the process illustrated b…
The Q in Quality stands for Questioning. As a good auditor, not only should you be asking the appropriate questions, you need to also have the right technique in asking questions.
These are my 10 tips below….
Be clear why you are asking the question; what is it you are hoping to achi…
How can airlines keep the required temperature range in the cargo hold during flight?
An increasing number of temperature-controlled pharmaceuticals, of different temperature ranges, are being flown all over the globe.
For airlines, it is quite a challenge to keep the temperature between t…
https://www.youtube.com/watch?v=PiCogFq9u3o
This short video clip, based on ICH Guidelines, provides a succinct summary on Quality processes which assess, document and control consistently the sourcing, storing, manufacturing and Quality Control testing for medicinal products. It provides …
https://www.youtube.com/watch?v=QNwWdEoSzg8&feature=emb_title&ab_channel=inglasiapharmasolutions
We will not REALLY know how to avoid an incident in the future if we hadn’t fully learnt from our initial mistakes.
By taking a step back, documenting a full analysis of the incide…
