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…
Change is always hard to accept. However, experiencing the EU MDR transition from MDD (Medical Device Directive) in The Supplier Quality department, was not so challenging after all. At the time of starting the transition it did appear to be a daunting task. However, by separating all new clause…
https://www.youtube.com/watch?v=vzuTP6NltUg
It is vital that organisations prepare themselves ahead of regulatory authority inspections for GMP, GDP, GCP or GPvP.
There are two fundamental aspects to consider in the preparation:
Documentation applicable to the inspection is present,…
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