Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. To that end, iTFlow® provides a front-line software interface to measure kinetic energies, vortexes, and shear stresses inside the heart without the need for complex in-house engineering software. Dr. Itatani, MD, Ph.D.,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

European Pharmaceutical Review

FEBRUARY 24, 2023

The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. With a myriad of potential techniques that could be applied to purify new protein drugs, years of experience will be needed to know the best approach to take to optimise yield, purity and cost.

Food and Drug Administration 87

Food and Drug Administration Engineering Specialization Food 87

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 86

Manufacturing Pharma Food and Drug Administration Safety 86