符合GXP的校准：从表格483和警告信中学习

Life Science

In this webinar we briefly outline the practices, processes and regulations governing calibration in GxP-regulated applications. We also analyze several calibration-related Form 483s and Warning Letters issued over the last few years in a range of regulated industries (Drugs, Medical Devices, Nutraceuticals, and Cosmetics). Each Form 483 and Warning Letter is a cautionary tale for those calibrating instruments and devices for use in federally regulated applications.

符合GXP的校准：从表格483和警告信中学习

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Vaisala的高级监管专家Paul Daniel与Heather Wade Group，LLC的Heather Wade一起加入。保罗和希瑟（Paul）和希瑟（Heather）将审查几封警告信和483个观察结果，以了解每个校准失败的技术方面，并讨论可以解决违法行为的原理和实践。人非圣贤孰能;无法正确校准可以导致执法行动。该网络研讨会提供了有关如何满足FDA校准要求并避免处理此类操作的实用课程。

韦比纳后的问答视频

该网络研讨会是为：

Calibration Managers
Quality Assurance & Quality Control
设备管理
信息技术
法规合规性
engineers
Process Managers
项目经理

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演讲者

保罗·丹尼尔（Paul Daniel），瓦萨拉

高级GXP监管合规专家

保罗·丹尼尔（Paul Daniel）是Vaisala的高级GXP监管专家。他在GMP监管的行业工作了20多年，帮助制造商在广泛的资格项目中运用良好的制造实践。他的专长包括映射，监视和计算机化系统。在Vaisala，Paul负责监督并指导Vaisala Viewlinc环境监测系统的验证计划。他担任客户倡导者，以确保ViewLinc环境监测系统符合生命科学和受监管应用程序的要求。保罗毕业于加州大学伯克利分校，拥有生物学学士学位。

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Heather Wade

Metrologist

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Heather Wade is an ASQ-CCT and ASQ-CQA metrologist. Before moving to her career in calibration, Heather’s experience included work as a microbiologist, filter test specialist, laboratory compliance officer, and extraction and analytical chemist. She is also a co-author of The Metrology Handbook, 2nd Edition.