Originally posted on Regulatory Focus – a RAPS publication The new EU Clinical Trials Regulation represents the most significant overhaul...
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Quality Assurance Strategies
Contact Surface and Hand Disinfection – Applying Pharma’s Disinfectant Efficacy Concepts for COVID-19
By Tracy TreDenick-Fricke, BioTechLogic, Head of Regulatory and Quality, and Senior Consultant Most of us now understand that SARS-CoV-2 (the cause of COVID-19) is often transmitted via respiratory droplets. However, SARS-CoV-2 is also spread by contaminated contact surfaces and hands, but all contact surfaces are not created equally. A chart published by the Journal of Hospital Infection is quite helpful for understanding the persistence of the virus on various surfaces.
Why Data Integrity Is More Important Than Ever
By Ashley Ruth, Senior Consultant, Analytical Services, BioTechLogic The pharmaceutical and biopharmaceutical industries must give immediate and strategic consideration to...
The FDA’s Groundbreaking Strides Toward a Quality-Centric Regulatory System
Two famous pharmaceutical industry quotes encapsulate industry thinking and the push for progress in recent years. Upon launching Pharmaceutical cGMPs for the 21st Century –...
Why Pharmaceutical Data Integrity Is More Important Than Ever
With radical pharmaceutical industry changes in the air, the importance of data integrity and the steps the pharmaceutical industry must take are clear. By Ashley Ruth,...
