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Antibody Development - Departmental Job-Skill Training 抗体开发-部门工作技能培训
发布日期: 2007-08-01
概述:描述抗体开发部门员工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,并符合良好生产规范的培训要求。适用于抗体开发部所有员工,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:抗体开发部门培训清单关于本文件: 这不是一个通用模板,它是一个1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 employees in the antibody development department. Provides the necessary training to assure that all employees are able to perform their assigned functions and the training requirements of Good Manufacturing Practices. Applicable to all Antibody development department employees 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:Antibody Development Department Training ChecklistAbout This Document:This is not a generic template, it's a 1-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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