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The past 30 years have seen regulators of GxP environments creating guidance to accommodate new technologies that are increasingly adopted in regulated industries. The FDA and the European Commission published 21 CFR Part 11 and Annex 11 respectively to ensure that computerized and automated systems did not create more risk than manual paper-based systems. Meanwhile, vendors of continuous monitoring systems for regulated environments, like Vaisala, have risen to the dual challenge of both regulations, while meeting the operational needs of GxP-regulated organizations by ensuring systems include risk-reduction features such as:
•文档签名选项
•记录保护
•限制系统访问
• 审计跟踪
• Operational Checks
•权威检查
•设备检查
• Training modules
These, along with other features that aid in compliance, have changed how environments are monitored and how companies can reduce risk to product efficacy. However, even with the inclusion of system features that aid in compliance, the responsibility to comply with GxP regulations still depends predominantly on how a system is deployed, used, and maintained. In this webinar, we breakdown the requirements of 21 CFR Part 11 and Annex 11 as they relate to environmental monitoring systems and show how simple compliance with the “Elevens” can be with the proper use of your monitoring system.
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Paul danielははシニアレギュラトリ・コンプライアンスエキスパートですです。。。规制が必要必要なな业界业界业界业界でででででででで年年年年にわたりにわたり,,医薬品医薬品企业企业企业様様の优れ优れたたた制造制造プラクティスその専门领域に,マッピング,,システムなどが含まれます。
ViewLinc环境环境环境环境システムのプログラムを监督・ ・ててていいいますます。。。またまた,またまたまたまた环境环境环境环境环境モニタリシステムがが,ライフライフサイエンスととと规制规制规制规制规制环境下下アプリケーションアプリケーションのののののの担ってい。
さらに、ブログの寄稿、ウェビナー、世界各地でのセミナーを通して、GMPに関する見識を提供しています。要求の厳しいGxP業界における専門知識は、製品の品質のために計測が重要である業界すべてに適用することができます。Paul Daniel はカリフォルニア大学バークレー校で生物学の学士号を取得しています。