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05.11.21 FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
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In this free live webinar, we will provide an overview of the strategy to speed up the migration from a vial to a pre-fillable syringe when developing a vaccine. We will discuss the different packaging characteristics, assess the syringe platform, and present what Stevanato Group can offer to support pharma partners in delivering a safe and effective vaccine.
Featured Editorial
On April 14, 2021, the FDA released a new guidance,
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance and shares how to submit public comments for FDA consideration.
01.28.21 When Pharmaceutical Automation Projects Fail: Averting Disaster Through Risk Assessment
With the spread of SARS-CoV-2 (COVID-19) intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring life-saving drugs to market. Attend this webinar to learn more about bringing life-saving drugs to market faster without impacting product quality, safety, or efficacy and the impacts and comparisons of classic platforms vs. new-generation platforms. And more!
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Automation does not always result in success, and poor automation can be as damaging to the pharmaceutical organization as no automation at all. This article addresses what happens when automation goes wrong and how mistakes can be avoided by adopting a risk-centric approach.