概述:描述设备工程职能部门/部门人员的工作技能培训要求。提供必要的培训，以确保所有员工能够履行其指定的职能，并满足良好制造规范的培训要求。本培训SOP适用于所有全职工程部员工，管理层可自行决定是否适用于临时员工、合同员工和顾问。包括符合21 CFR第211.25和820.25部分的规定。包括的章节:目的、范围、责任、参考文件和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括的附件/附录:工程部培训清单关于本文件:这不是通用模板，而是6- page程序实际上是在FDA监管机构的设备工程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在做什么，谁会从中受益:工程经理质量保证经理工程开发和制造人员

Summary:Describes job skill training requirements for personnel in a device engineering function/department. Provides the necessary training to assure that all employees are able to perform their assigned functions and meet the training requirements of Good Manufacturing Practices. Applicable to all full-time Engineering Department employees, and at the discretion of management, this training SOP may also apply to temporary employees, contract employees, and consultants. Includes provisions for compliance with 21 CFR Parts 211.25 and 820.25.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Engineering Department Training ChecklistAbout This Document:This is not a generic template, it's a 6-page procedure that was actually created and used in the Device Engineering 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:Engineering ManagersQuality Assurance ManagersEngineering Development & Manufacturing Personnel