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Benchtop NMR for streamlined and compliant pharmaceutical Quality Control
Benchtop NMR for streamlined and compliant pharmaceutical Quality Control
网络研讨会

用于简化和符合要求的药品质量控制的台式核磁共振

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研讨会简介

随着 ICH Q2(R2) 和 ICHQ14 的发布，ICH Q8 在生产过程中引入的现代分析质量设计（Quality by Design - QbD）范式扩展到了质量控制（QC）。现在鼓励采用生命周期、基于风险的管理方法，将质量纳入分析程序。这种全新的分析质量设计（AQbD）的概念要求详细了解分析程序的各个方面，以进一步提高可报告值的可信度和可靠性，确保产品质量，最终保证用药者的安全。

这一新的强化框架鼓励采用灵活的程序，并要求采用现代化的方法和技术。核磁共振 (NMR) 与这些新概念完美契合。NMR 依靠普遍和绝对的原则，可以大大简化风险评估并简化分析程序管理。它的优势在于方法可操作设计区域大，是少数几种可利用平台程序新概念的技术之一，在平台程序中，无需对程序进行重大更改即可测试多个产品的质量属性。此外，由于技术本身的合理性，鉴定和监测也得到了简化。

本次布鲁克英文网络研讨会将探讨在定性和定量应用中使用紧凑型、无需制冷剂的台式核磁共振系统进行以 AQbD 为导向的现代质量控制程序的优势。开发灵活而简单的 NMR 鉴定程序是最有效的方法之一。

举办时间：

2024 年 9 月 10 日

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研讨会亮点

  • 核磁共振（NMR）在开发和管理现代质量控制分析程序的优势
  • 在质控实验室使用紧凑型无制冷剂台式核磁共振波谱仪使用NMR技术
  • 符合 GMP 要求的台式核磁解决方案

主讲人简介

Dr. Valentin Poirier

Solutions Product Manager BioPharma, Bruker BioSpin

Valentin Poirier holds a Ph.D. in chemistry from the University of Rennes, focused on organometallic catalysis and polymers. He then joined the pharmaceutical industry and pivoted to the analytical field, focusing on NMR and MS. Over the past decade, he managed the NMR and MS analytical platforms of CROs (Albhades, Evotec). As a technical expert, he contributed to dozens of analytical projects development for pharmaceutical applications and quality control, with a customer-centric and problem-solving approach. He joined Bruker BioSpin in 2024 as a Solution Product Manager in the Pharma Team. In this role, he collaborates with the pharmaceutical industry to advance NMR solutions tailored for Quality Control, Compliance and the CRO/CDMO customers.

Dr. Fabrice Moriaud

Product Manager for GxP solutions, Bruker BioSpin

Fabrice Moriaud, Ph.D. is Product Manager for GxP solutions. In his role as Solutions Development Manager at Bruker BioSpin, he brings extensive experience in leading the development of solutions for the Pharma industry. Trained as a chemist, Fabrice has a strong academic background in EPR and NMR.

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