Dr. jinesh malde is examining how to identify and manage contamination sources and address risks with effective strategies. He is uncovering key techniques for managing and mitigating elemental impurities at the 2nd Annual Pharma Impurity Conclave 2024. #EminenceBusinessMedia #EBMPIC2024 #EminenceGroupVentures
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Starting the day with a focus on the most challenging topic, nitrosamine and mutagenic impurities, Dr. Ramesh Jagadeesan is addressing the root causes of NDSRIs and showcasing advanced tools to predict impurities and identify potential risks in real-time at the 2nd Annual Pharma Impurity Conclave 2024. #EminenceBusinessMedia #EBMPIC2024 #EminenceGroupVentures
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⬇️ Download our latest technical poster "NDSRI Risk Assessment and Trace-Level Analysis of N-Nitrosamines": https://okt.to/YbVDT4 We collaborated with Waters Corporation to develop a reliable UPLC/MS/MS method for quantifying trace levels of N-nitroso-sertraline in drug products, utilising their mass spectrometry technology alongside LGC reference standards. With increasing regulatory scrutiny from the FDA and EMA, this case study reveals how our method can help ensure your products meet the highest safety standards. #PharmaQuality #Nitrosamines #AnalyticalExcellence #analyticalchemistry
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Final opportunity to sign up for our Nitrosamines in Focus webinar! With nitrosamines identified as powerful carcinogens, they are now scrutinized by regulatory bodies. Are you prepared to tackle the intricate challenges of detection, control, and adherence to regulations? Participate in our webinar on Sept. 12, 2024 at 10:00am ET to discover how to: ✅ Grasp the regulatory standards and directives ✅ Apply effective analytical techniques ✅ Reduce risks within your manufacturing processes ✅ Gain insights from practical case studies Sign up here ➡️ https://gag.gl/kbe3xx #Nitrosamines #CarcinogenControl #PharmaceuticalRegulations #MedicalDevices #RiskAssessment #AnalyticalMethods #ComplianceStrategies #RegulatoryRequirements #LabBestPractices #HighRisk #Webinar #PharmaCompliance #ProductSafety #AnalyticalChemistry
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Final opportunity to sign up for our Nitrosamines in Focus webinar! With nitrosamines identified as powerful carcinogens, they are now scrutinized by regulatory bodies. Are you prepared to tackle the intricate challenges of detection, control, and adherence to regulations? Participate in our webinar on Sept. 12, 2024 at 10:00am ET to discover how to: ✅ Grasp the regulatory standards and directives ✅ Apply effective analytical techniques ✅ Reduce risks within your manufacturing processes ✅ Gain insights from practical case studies Sign up here ➡️ https://gag.gl/kbe3xx #Nitrosamines #CarcinogenControl #PharmaceuticalRegulations #MedicalDevices #RiskAssessment #AnalyticalMethods #ComplianceStrategies #RegulatoryRequirements #LabBestPractices #HighRisk #Webinar #PharmaCompliance #ProductSafety #AnalyticalChemistry
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Download our latest technical poster "NDSRI Risk Assessment and Trace-Level Analysis of N-Nitrosamines": https://okt.to/Tm04ae We collaborated with Waters Corporation to develop a reliable UPLC/MS/MS method for quantifying trace levels of N-nitroso-sertraline in drug products, utilizing their mass spectrometry technology alongside LGC reference standards. With increasing regulatory scrutiny from the FDA and EMA, this case study reveals how our method can help ensure your products meet the highest safety standards. #PharmaQuality #Nitrosamines #AnalyticalExcellence #AnalyticalChemistry
Download our latest NDSRI poster
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Thoughts on this? >> As confidence falls, biopharma companies take precautions with Chinese partnerships, survey finds >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #productmarketing #pharmaceutical #biotech #pharma
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Detection and quantification of single chain rFVII impurity in final drug products by SE-UPLC and CE-SDS as an alternative to SDS-PAGE
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🌟 Celebrating Stability Chamber Month! 🌟 Our colleagues at Stability Hub have declared November as Stability Chamber Month! To kick it off, Parameter Generation & Control, Inc. has collaborated with them on an insightful article featuring a real case study where we discuss key steps taken to enhance performance monitoring and the critical role of preventative maintenance programs can play. Be sure to give it a read and let us know your thoughts in the comments. https://lnkd.in/eNmFdpHf 💡 Also To dive deeper into this topic, we’re thrilled to announce a webinar with Stability Hub on November 14. Join us as we explore how to develop effective preventative maintenance strategies for your stability chambers, ensuring your products remain safe and compliant. Don’t miss this opportunity to gain valuable insights that can enhance your stability management practices and protect your investments! #StabilityChamberMonth #Pharma #Webinar #parametergenerationandcontrol #togetherforabrighterfuture #parameterhumitycontrol #temperaturechamber #stabilitychamber
A Stability Chamber Problem - StabilityHub
https://stabilityhub.com
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NDA Partners Experts, Dr. Daniela Drago and Dr. Laura Inés Salazar Fontana, discuss how ICH Q14 can ease regulatory risk around impurity and potency testing in an article entitled "Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?" published by BioProcess Online. #ndapartners #regulatorystrategy #regulatorysciences #qualitybydesign https://lnkd.in/eYG8-73K
Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?
bioprocessonline.com
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Final opportunity to sign up for our webinar on Nitrosamines in Focus! Nitrosamines, recognized as strong carcinogens, are currently the focus of regulatory bodies. Are you prepared to tackle the intricate challenges of detection, control, and adherence to regulations? Participate in our webinar scheduled for Sept. 12, 2024, at 10:00am ET to discover how to: ✅ Grasp the regulatory standards and advice ✅ Employ effective analytical techniques ✅ Reduce risks within your manufacturing processes ✅ Gain insights from practical case studies Sign up here ➡️ https://gag.gl/kbe3xx #Nitrosamines #CarcinogenControl #PharmaceuticalRegulations #MedicalDevices #RiskAssessment #AnalyticalMethods #ComplianceStrategies #RegulatoryRequirements #LabBestPractices #HighRisk #Webinar #PharmaCompliance #ProductSafety #AnalyticalChemistry
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