Anyone dealing with the subject of GMP inevitably comes across the topic of "qualification". It quickly becomes clear that this is a time-consuming, costly and personnel-intensive task. But how can resources be saved and still comply with the regulations correctly?
In simple terms, the term "qualification" refers to proof that technical systems work as planned. However, the goal is often overshot. Tests are repeated, reviews are carried out several times and pointless amounts of paper are generated. Often, reviews performed under the aspect of qualification are already part of the usual technical reviews. Here it is worthwhile to follow the modern approach of integrated qualification. For devices that can be standardized, further savings potential can be unlocked.
This is the subject of the technical presentation by Dominik Unglaub, Consultant gempex GmbH:
Standard devices – Qualification smart implemented!
April 20, 2023, Lounges Karlsruhe, 11:45 a.m., room 3.
- Qualification - Status Quo
- What characterizes standard devices?
- How much effort does the qualification of standard devices require?
The lecture shows a way to qualify standard equipment smartly, i.e. with as little effort as possible. A concept is also presented for carrying out the qualification as integrated proof that the plant is "fit for intended use". An insight into the exemplary structure and content of the qualification documents is given.
Interested parties can register for the lounges free of charge until April 14 by entering the code 6BH1ZK5C.
The gempex expert team is available for you:
for a direct discussion at the gempex booth, D12, area VIP3000 or via email@example.com.
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