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Research and Development Flow Cytometry Job-Skill Training 流式细胞仪工作技能培训的研究与开发
发布日期: 2007-08-01
概述:描述了进行流式细胞术分析的研发(R&D)员工的工作技能培训要求。旨在确保所有人员能够履行其分配的职能,并满足医疗器械设计中GMPs和/或设计控制的培训要求。适用于进行流式细胞仪检测的人员,包括全职和临时员工、合同员工和顾问。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括附件/附录: 研发流式细胞术培训清单关于本文件:这不是一个通用模板,它是一个5页的程序,实际上是在FDA监管机构的实验室研发操作中创建和使用的。公司特定信息(名称、地址、一些图片、专有产品信息等)已被编辑,但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点,将你文档的质量与你所在行业的同行进行比较,了解你所在行业的其他公司实际在做什么,谁将从中受益:流程开发人员方法开发人员质量控制人员
Summary:Describes job skill training requirements for Research and Development (R&D) employees performing flow cytometry assays. Intended to assure that all personnel are able to perform their assigned functions and that they meet the training requirements of GMPs and/or Design Control in Medical Device Design. Applies to personnel performing flow cytometry assays including full-time and temporary employees, contract employees and consultants.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:R&D Flow Cytometry Training ChecklistAbout This Document:This is not a generic template, it's a 5-page procedure that was actually created and used in the Laboratory R&D operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Process Development PersonnelMethod Development PersonnelQuality Control Personnel
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