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A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
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United statesKenneth farrugiaEster lovsin barleJove grahamRalph basileJessica grahamMallory degennaroJayen diyoraDavid dolanAndreas flueckigerSpiro megremisIoana gheorghievJoel youngJoshua anthesIoanna maria gerostathiChristophe gamblin

RNA Interference With Zilebesiran for Mild to Moderate Hypertension

This phase 2 randomized trial examines the antihypertensive efficacy and safety of different zilebesiran dosing regimens.

United statesUnited kingdomUniversity of chicagoEteläuomen läiEli lillyVifor pharmaPharmagenesis cardiffGeorgel bakrisBoehringer ingelheimAmerican heart association comprehensive hypertension centerNovo nordiskInternational conference on harmonizationDepartment of medicineAmerican heart association scientific sessionsStudy groupGroup information

Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety

Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
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United statesSan diegoTheo zacharatosAmanda mcfarlandYork universityValsource incParenteral drug associationUniversity of floridaRegulatory affairsManagement instituteStevens institute of technologyInternational conference on harmonizationUniversity of californiaPatrick mainsExample raw materialPharmaceutical engineering

How do cell therapy manufacturers ensure quality in critical raw materials?

This article explores the quality control practices in place for cell therapy manufacturers when usingcritical raw materials.

Aimee molineuxEuropean committee for standardizationInternational conference on harmonizationLaboratory standards instituteSponsored contentEuropean directorateInternational conferenceSample curveAnalytical procedures textConfirmation assayEuropean committeeVitro diagnostic reagentsImage creditContent policyNews medical netCritical raw materials

1 Day Online Process Validation Guidance Requirements Course: Focus on FDA and EU Annex 15: Qualifications and Validation

1 Day Online Process Validation Guidance Requirements Course: Focus on FDA and EU Annex 15: Qualifications and Validation
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United statesBarrya friedmanLaura woodUnion carbideOhio state university in microbiologyE st office hours callOffice hours callAmerican cyanamidBecton dickinsonSigma chemical coInternational conference on harmonizationCambrex bio sciencesMichigan state university in microbial geneticsOhio state universityValidation guidance requirementsValidation training