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1.6.1
Extension - what is the key to do it in a compliant way?
I'm sure you need to work with deadlines. 30 days' lead-time for deviation or complaint investigation, also hard deadlines for CAPAs and...
brunnerbalazs
Dec 1, 20233 min read
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Self-inspection vs internal audit
In big pharma, there are usually two levels of 'periodic self-check': self-inspection and internal audit. But what is the real difference...
brunnerbalazs
Sep 19, 20234 min read
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Organization change - how to handle it in GxP environment?
Organization change is always fashionable. 'Let's start to centralize', 'Let's start to decentralize', 'Let's dedicate a team'. There may...
brunnerbalazs
Jul 3, 20231 min read
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