Course Title:
CGMP Training (Medical Devices) CGMP 培训(医疗器械)
CGMP Overview, Auditing and Implementation
CGMP 纵览,审核和执行
CEU:
0.4
Prerequisites: None
Course Time Period:
You can take training at your own pace. You can logon
and logout as many times as needed. You can re-take the
exam as many times as necessary until you pass the exam
and an online certificate is issued.
Key Session Topics:
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General Provisions总条款
Scope范畴
Definitions定义
Quality System质量体系
Quality System Requirements质量体系要求
Management Responsibility管理职责
Quality Audit质量审核
Personnel人员
Design Controls设计控制
Design Controls设计控制
Document Controls文件控制
Document Controls文件控制
Purchasing Controls采购控制
Purchasing Controls采购控制
Identification and Traceability 鉴别和起源
Identification 鉴别
Traceability 起源
Production and Process Controls 生产和流程控制
Production and Process Controls 生产和流程控制
Inspection, Measuring, and Test
Equipment 检验,测量和测试仪器
Process Validation 流程确认
Acceptance Activities 验收活动
Receiving, In-Process and Finished
Device Acceptance 接收,半成品和成品器械
Acceptance Status 验收状况
Nonconforming Product 未确认产品
Nonconforming product 未确认产品
Corrective and Preventive Action 矫正和预防行动
Corrective and preventive action 矫正和预防行动
Labeling and Packaging Control 商标和包装控制
Device Labeling 器械商标
Device Packaging 器械包装
Handling, Storage, Distribution, and
Installation整理,存储,分配和安装
Handling整理
Storage存储
Distribution分配
Installation安装
Records记录
Records General Requirements 总体要求记录
Device Master Record 主要器械记录
Device History Record 历史器械记录
Quality System Record质量体系记录
Complaint Files投诉文件
Servicing 服务
Servicing服务
Statistical Techniques 统计技术
Statistical Techniques统计技术
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FDA/CGMP Medical Devices Executive Overview-Management
Review for meeting FDA req Chinese
Final
Exam
Certificate Issuance:
Online Certificate is issued upon completion of course
and Final Exam
Courses Approval:
All courses are approved by Quality University and the
certificate issued has Quality University registered
mark and certificate number.
Please follow instructions below for taking the course:
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Make sure you create a separate login account for
each person taking the course. The name on the
account should match the name of the person who is
taking the course and whose name will appear on the
certificate. Once created the contact name cannot be
changed and the course cannot be reassigned to a
different name.
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you have purchased that have not yet been completed
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Select your course.
You can logon and logoff as many times as needed until
the course is complete. In order to continue a course
already in progress after you have logged off:
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log into Quality University through by clicking the
"My Account" link
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Click on "My Courses" to see a selection of courses
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Select your course. You may take the course and exam
at your leisure.
You may retake the exam as many times as needed until
a passing score is achieved.
For additional questions, you may contact us at our
Help/Support Link located on the bottom of the Homepage.
Once you complete the course with a passing score on the
exam you will be issued a certificate.
Please print this cerificate for your own records. If
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reprint a certificate for any training you have
completed.
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Computer configuration needed for the course:
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Microsoft Internet Explorer
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Make sure all Pop-Up Blockers are disabled, in other
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Please find the link listed below to access the
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What is CGMP?
Application of CGMP for Medical Devices
CGMP Requirements for top management
Roles and responsibilities for upper management and
executives in implementing and supporting an CGMP
Auditing Questions
Certificate upon completion of course with passing
scores.
Flexible course design allows students to take
courses/exam at their own pace.
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