会议时间
10/26/2022,10:00PM-11:00 PM
北京时间:10月26日 晚10:00 -11:00 点
会议预告
In this webinar, potential challenges during the implementation of a bio-fluorescent particle counting system will be discussed, sharing the perspective of a consortium of four industry-working groups on navigating these challenges.
Bio-fluorescent particle counting (BFPC)technologies use the detection of intrinsic fluorescence to continuously enumerate bioburden levels in air or water samples. The reported unit is commonly referred to as an auto-fluorescence unit (AFU), which is not dependent upon growth like the traditional method. Examples of challenges include the perceived risk of regulatory inspectional observations and lack of acceptance, internal communication and acceptance, qualification strategy, and validation of a modern method that reports in a non-growth-based unit.
Information will be shared on ways to navigate common challenges encountered during the implementation of new technologies, on a BFPC modern microbiological method, and an industry working group collaboration that offers support to the industry with the implementation and use of modern microbial methods.
本次网络研讨会,将讨论生物荧光粒子计数系统实施过程中的潜在挑战,并分享行业工作组联盟在应对这些挑战方面的观点。
生物荧光粒子计数(BFPC)是通过检测生物粒子的固有荧光(也称为“自发荧光”)强度来检定空气或水样中的生物负荷水平。使用自发荧光单位(AFU,Auto Fluorescent Unit)对微生物进行计数,一个微生物被计为一个AFU,自动计数,无需培养。但这种现代微生物检测方法在实施过程中还面临着诸多挑战,包括监管检查缺少认知度、内部沟通与可接受度的风险、资质升级的挑战与应对战略,以及现代微生物检测方法的验证。
除了介绍BFPC现代微生物检测方法,以及如何应对新技术实施过程中遇到的共同挑战,本次研讨会还将分享一直以来行业工作组联盟的合作为实施和使用现代微生物方法提供的支持。
会议讲师(MV)
主办方简介
Since its inception in 2004, BioPhorum has become the open and trusted environment where senior leaders of the biopharmaceutical industry come together to openly share and discuss the emerging trends and challenges facing their industry.
自2004年成立以来,BioPhorum为生物制药行业提供了开放和值得信赖的环境及平台,与来自各领域的专家和高级领导者齐聚一堂,聚焦其行业的新兴趋势,分享并讨论新技术的实施和挑战。
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