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2024实验室质量控制及检测技术研讨会

直播时间:2024-09-21 09:00

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2024实验室质量控制及检测技术研讨会

实验室质量控制是一个系统性、综合性的过程,它涵盖了实验室管理的各个方面,包括人员培训、设备管理、试剂耗材管理、环境控制、检测方法选择、数据记录与分析等。通过科学、规范的质量控制手段,可以及时发现并纠正检测过程中可能出现的偏差和错误,确保检测结果的准确性和可靠性。

检测技术则是实验室质量控制的具体实施手段,它涉及到样品的采集、处理、分析以及结果的判定等多个环节。随着科学技术的不断发展,检测技术也在不断更新和完善,检测技术的多样性和先进性为实验室质量控制提供了有力的支持。

为此,蒲公英(苏州)医药服务平台联合药视网将于2024年9月21日举办“2024实验室质量控制及检测技术研讨会”。

 
嘉宾简介
  • 龚雁

    瑞士万通中国电位滴定仪和卡尔费休水分测定仪产品经理,有着将近20年的电位滴定和卡尔费休水分方面丰富的理论和客户实操经验。曾经多次参与电位滴定仪和卡尔费休水分仪测定相关的国家标准。

  • 叶非

    对中国、欧盟、美国FDA的药品生产质量管理有深入研究,擅长以法规、指南、GMP条款为基础,结合药品生产工艺及质量管理要求,从质量体系搭建、质量工具应用到质量文化建设等方面有丰富经验,曾带领团队多次通过中国、欧盟及美国FDA的GMP认证检查。《药品GMP指南》2023版“无菌制剂”、“厂房设施与设备”分册审稿专家、“质量控制实验室与物料系统”分册撰稿专家。 作为行业专家多次在药品生产质量管理主题活动/会议上做技术报告。

  • 马蕊华

    默克生命科学- 科学和实验室解决方案市场部标准物质产品经理,负责默克旗下Supelco品牌标准物质产品线(包括原Sigma-Aldrich、Supelco、Cerilliant、Merck等品牌)的管理和市场推广工作。一直专注于生命科学和分析检测领域,十年以上的实验室技术、市场等工作经验,了解中国分析行业的发展及相应的实验室需求与法规要求。

  • 柴海毅

    20年跨国制药企业质量管理工作经历。先后在西安杨森制药有限公司、上海雅培制药有限公司、第一三共制药(上海)有限公司工作,历任微生物主管、QC经理等,组织协调制药企业的质量管理与质量检验工作。 有丰富的制药企业实验室管理工作经验、擅长无菌检验、非无菌药品微生物检验,在微生物偏差调查、洁净室环境监测方案、培养基模拟灌装方案的设计和实施、等方面有丰富的理论知识和实践经验。 在上海诺狄生物科技有限公司期间,成功研发并生产出国产成品培养基,在抗生素生产环境监测方面有深入的研究。上海诺狄公司为国内众多抗生素生产企业提供完整的环境监测方案,许多案例成功通过FDA、欧盟的现场检查。

  • 王晶晶

    安捷伦分子光谱资深应用工程师,负责安捷伦红外、紫外、拉曼、荧光等产品的技术支持,包括应用开发、培训等工作。

  • 高峥

    奥星集团实验室质量管理专家,拥有丰富的实验室质量管理及操作经验,精通实验室设备项目验证及实施,熟悉设备验证的相关法规及实施流程,对于药品相关方法学的开发及对应的验证工作有着深厚的造诣。

  • 曾文亮

    迪哲医药CMCRA副总监、公众号“文亮频道”主理人,有近18年药物研发经验。先后任职于某大型CRO医药研发公司、USP大中华区研发中心和港资药厂等,主导药厂QC实验室通过国家GMP检查和WHO审计,擅长新药研发与注册申报,积累了近十个小分子新药中美IND申报和两个1类新药上市申报经验。

  • 姜洪宇

    多年制药行业EMS系统实施经验,现任德图仪器医药解决方案部门应用工程师,在制药行业的设备验证和EMS系统合规性咨询具备丰富的项目经验,负责德图EMS系统技术支持和推广工作,为30余家国内外知名制药和疫苗企业以及政府部门提供专业的EMS系统咨询和实施工作,合作伙伴包括金赛药业,兴齐眼药,百济神州,智享生物,民海生物,科兴生物,施贵宝等知名企业

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NEWS & INFORMATIONS
新闻资讯
我们投资2000万美元在瑞士建设新实验室
我们已宣布在瑞士的布克斯投资2000万美元建设一个新的实验室设施,以满足参考物质业务的快速增长需求。Introduces new synthetic cholesterol product nine months ahead of scheduleOffers high purity, scalability, and consistent qualityOne of a few companies that produces lipids in quantities needed to meet demand for mRNA therapeutics, including Pfizer-BioNTech Covid-19 VaccineDarmstadt, Germany, May 26, 2021 — To meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics, Merck, a leading science and technology company, has launched a new, high-purity synthetic cholesterol product, nine months ahead of schedule.“Tapping into two decades’ experience of developing and manufacturing high-quality lipids, we designed a proprietary process to bring our new SAFC® synthetic cholesterol product to market nearly a year early,” said Andrew Bulpin, head of Process Solutions, Life Science, at Merck. “With the introduction of our new SAFC® synthetic cholesterol product, we have increased our capacity by 50 times, helping biomanufacturers bring lifesaving therapies to patients faster.”Merck manufactures lipids in Schaffhausen, Switzerland; Darmstadt, Germany; and St. Louis, Missouri, USA. While there are animal-derived and synthetic versions of cholesterol available on the market, Merck’s synthetic cholesterol product offers high purity, scalability, and consistent quality.This neutral lipid, used in commercially marketed products, is more than 99 percent pure; offers high batch-to-batch consistency and is scalable under commercial GMP. Merck is one of a few companies in the world able to produce the quantities needed for lipid nanoparticle manufacturing and meet the quality requirements for mRNA therapeutics.The launch of this new product follows the company’s acquisition of AmpTec, a Hamburg, Germany, based mRNA contract development and manufacturing organization. By combining AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing, Merck can provide a truly integrated offering across the mRNA value chain. Merck has more than 20 years of experience developing and manufacturing high-quality lipids, following GMP processes. The company provides regulatory support through all phases of clinical development and commercialization, as well as deep analytical expertise.Merck is collaborating with more than 50 companies to support their efforts in the development and production of Covid-19 vaccines and treatments, providing custom lipids, as well as other critical raw materials, processing equipment and services used in mRNA drugs and vaccines manufacturing. In early February 2021, the company announced the extension of its strategic partnership with BioNTech to significantly accelerate the supply of urgently needed lipids and increase the quantities to be delivered toward the end of 2021. The lipids will be used for the production of the Pfizer-BioNTech Covid-19 vaccine.The company recently announced the addition of a single-use assembly production unit at its Life Science Center in Molsheim, France. The company also recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California; Madison, Wisconsin; Jaffrey, New Hampshire; and Danvers, Massachusetts. At the latter site, Merck is working to double the local single-use production capacity by the end of 2021. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and Merck’s capabilities to support growing global demand for lifesaving medications and to make significant contributions to public health.About MerckMerck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of
我们的COVID-19行动
科学界的疑问:如何战胜新冠病毒?随着大量新闻报道帮助人们时刻获悉COVID-19大流行的相关资讯,科学界正在发问:如何战胜新冠病毒?如今人们迫切需要解决这一问题的解决方案,而致力解决这一全球难题的解决方案的人员必须权衡各项优先事项,以保护公共健康、在动荡情况下安全运行及制定恢复计划。在COVID-19应对期间,生命科学公司和其他供应商需要关注员工的健康和安全,同时确保他们的技术、产品和服务受到全球生物技术、制药公司和学术实验室客户信赖。优先级1:确保员工安全。对于COVID-19大流行期间仍继续维持基本业务运行的企业,对工作场所安全提出了最大的取舍问题。默克是一家全球生命科学企业,员工遍布全球59个生产基地和100个分销中心。疫情期间他们以轮岗方式继续工作,致力保持客户所依赖的高质量。今年一月正值中国疫情高峰,默克一组生产员工加班加点,为170多个关键订单生产线提供支持。本地销售团队远程管理项目,以便为从事分子开发的客户提供必要的产品和服务。这些员工的付出推动了抗击COVID-19大流行的关键研发工作。优先级2:满足客户需求。COVID-19疗法和疫苗的开发和生产竞赛有赖于众多供应商。默克动员全球供应链力量,向20多家诊断公司提供关键材料,确保80多项专业疫苗和治疗方法计划截至3月底的连续性。但单单满足当前需求并不足够,还需预测其他需求。优先级3:加速全球复苏。除推动疫苗和治疗方法开发外,参与这一行动的科学家和研究人员还需利用学习、资源和技术来对抗这种病毒。复苏方案对于摆脱COVID-19危机至关重要。在应对病毒大流行的同时,人们已经开始协作加快行动速度。默克召集了创新委员会——全公司的研发负责人、生物学家、化学家、数据科学家和工程师——帮助设法应对疫情。该小组正在与科学专家举行开放会议,以分享知识并构建专门的抗击病毒方案。通过这种优先级的权衡平衡,全球科学界可共同对抗COVID-19病毒,有望找到应对方案。
我们在上海设立了规模最大的M Lab™协作中心。
我们在上海设立了M Lab™协作中心,其规模位居全球9个中心之首。Focus on improving and optimizing drug discovery, development and manufacturingIntegrated lab with customizable solutions, validation services, training and hands-on applicationsShanghai center is newest and largest addition to Merck’s global network of nine M Lab™ Collaboration CentersDarmstadt, Germany, July 10, 2020 — Merck, a leading science and technology company, today opened its M Lab™ Collaboration Center in Shanghai, the company’s largest of nine centers worldwide.“With the booming pharmaceutical industry in Asia and greater emphasis on novel drug therapies, we see an increase in R&D on leading-edge treatments including cell and gene therapies in China,” said Udit Batra, member of the Merck Executive Board and CEO, Life Science. “Our M Lab™ Collaboration Center offers customizable solutions and services that help bio pharmaceutical and biologics companies improve their processes from drug discovery, development to manufacturing — saving costs and increasing speed to market.”With a total lab size of approximately 10,000m2, Merck’s newest M Lab™ Collaboration Center is located in Pudong, at the heart of the biomedical sciences and research community in Shanghai.The new M Lab™ Collaboration Center in Shanghai offers customizable solutions tailored for China’s Life Science community to help advance drug development. It includes Pilot Scale and Process Development support labs that offer non-GMP (Good Manufacturing Practice) lab space where pharmaceutical and biopharmaceutical manufacturers can explore ideas, learn innovative techniques and work side-by-side with the company’s scientists and engineers to solve critical process development and production challenges. Customers can participate in product demonstrations, hands-on training, formal bioprocessing educational courses and experiments, as well as apply best practices and new approaches to develop, optimize and scale-up processes and simplify global technology transfer.Customers will also be able to tap into the following Merck offerings:Lab Management Software: This digital platform helps scientists improve efficiency and processes by automating workflows and connecting lab instruments via the cloud. The software centralizes research information, allowing researchers to move away from transferring and documenting data by hand, increasing productivity and helping them to avoid costly errors.Customized Cell Culture Media facility: This facility develops cell culture media, which are used in the production of biopharmaceuticals and will be used for non-GMP pilot production.Solid Dose Formulation facility: This facility helps ensure drugs in tablet/capsule/powder form contain high quality excipients and active pharmaceutical ingredients. This facility will support customers in China and around the world.Additionally, the center will host a new BioReliance® End-to-End Solutions GMP manufacturing facility offering contract development manufacturing organization services to customers in China and Asia-Pacific.As a leading innovator in the pharmaceutical and biopharmaceutical industry, Merck is committed to playing an active role in China’s transformation into an innovation- driven economy. Through this new center, Merck will collaborate with local and regional customers to increase drug quality and safety and provide training and knowledge transfer.Follow Merck on Twitter @Merckgroup, on Facebook @merckgroup and on LinkedIn.About MerckMerck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of