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Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice

...(or critically assess existing controls) is a key use of the Health Based Exposure Limit studies. Risk Management requires a focus and a perspective as well as knowledge and data....

Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

...part, we explore the challenges ahead. Remote access to EHRs is something we have addressed during the pandemic, to facilitate source data verification (SDV) and monitoring. We have attached restrictions...