Risk-based GLP quality assurance programme
...is enough. For example, the procedures for handling and dealing with deviations, amendments, errors, change etc. These systems can generate a lot of data - what does it tell you...
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A fresh look at an old topic: Investigations in the GMDP environment
Posted by:
Callum McLoughlin, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
...justify taking - or not taking - certain actions are usually flawed. This is because there is a natural tendency to only include information and arguments that support the outcome...
Building resilience into clinical trial design and conduct during the pandemic
Posted by:
Gail Francis and Martin O'Kane, Posted on:
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Categories:
Compliance matters, Good clinical practice
...We would encourage Sponsors to monitor and evaluate the ‘flexible’ approaches to trial conduct compared with ‘traditional’ methods to gather case studies and establish best practice that can be shared...
Educating and engaging through our symposia
Posted by:
Mark Birse, Posted on:
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Categories:
Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
...our stakeholders - up to date with the latest regulatory changes and our current thinking, and for us to answer your questions. The events are a key part of our...
PIC/S 2016 - Manchester
Posted by:
Mark Birse, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate
...a long time we can track our hosting of the seminar back to 1973. 1987 - The business of pharmaceutical inspection (Cambridge) 1978 - Good manufacturing practice in tablet manufacture...
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