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Training in Chinese
Course Title:
FDA/CGMP Training (Medical Devices) CGMP 培训(医疗器械)
FDA/CGMP Overview, Auditing and Implementation
FDA/CGMP 纵览,审核和执行
CEU:
2.0
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.
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
内容
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
内容
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
FDA/CGMP for Medical Devices, Auditing/
Auditor/Implementation
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:
-
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.
-
Click on "My Courses" to see a selection of courses
you have purchased that have not yet been completed
-
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:
-
log into Quality University through by clicking the
"My Account" link
-
Click on "My Courses" to see a selection of courses
you have purchased that have not yet been completed
-
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
you need to reprint a certificate for any reason, visit
the "My Courses" link and you will have an option to
reprint a certificate for any training you have
completed.
QUALITY UNIVERSITY
mark is a registered trademark and should not be used by
any individual or companies without written approval of
Quality University.
Computer configuration needed for the course:
-
Microsoft Internet Explorer
-
Make sure all Pop-Up Blockers are disabled, in other
words, pop-ups are allowed
-
If you have any other issues,
please restart your computer
-
For any troubleshooting, refer to Help/Support
at:http://www.qualityuniversity.com/commerce/misc/onsite.jsp
-
If screen is blank, exit Internet Explorer and log
back in again
Corporate Accounts and Discounts:
Please find the link listed below to access the
Corporate Form:
http://www.qualityuniversity.com/commerce/misc/other.jsp |
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Key Session Topics:
Scope
Terms and Definitions
Management Responsibilities
Audit and Implementation Questions for Quality System Requirements
Requirements for Quality Audits
Audit and Implementation Questions for Quality Audits
General and Training Requirements for Personnel
Audit and Implementation Questions for General and Training Requirements for
Personnel
Requirements for Design Controls
Audit and Implementation Questions for Design Control
Requirements for Document Control
Audit and Implementation Questions for Document Control
Requirements for Purchasing Control
Audit and Implementation Questions for Purchasing Control
Requirements for Identification
Audit and Implementation Questions for Identification
Requirements for Traceability
Audit and Implementation Questions for Traceability
Requirements for Production and Process Controls
Audit and Implementation Questions for Production and Process Controls
Requirements for Process Validation
Audit and Implementation Questions for Process Validation
Requirements for Acceptance Status
Requirements for Nonconforming Product
Audit and Implementation Questions for Nonconforming Product
Requirements for Corrective and Preventive Action
Audit and Implementation Questions for Corrective and Preventive Action
Requirements for Device Labeling
Audit and Implementation Questions for Device Labeling
Requirements for Device Packaging
Audit and Implementation Questions for Device Packaging
Requirements for Handling
Audit and Implementation Questions for Handling
Requirements for Storage
Audit and Implementation Questions for Storage
Requirements for Distribution
Audit and Implementation Questions for Distribution
Requirements for Installation
Audit and Implementation Questions for Installation
Requirements for Records General Requirements
Audit and Implementation Questions for Records General Requirements
Requirements for Device Master Records
Audit and Implementation Questions for Device Master Records
Requirements for Device History Records
Audit and Implementation Questions for Device History Records
Requirements for Quality System Record
Audit and Implementation Questions for Quality System Record
Requirements for Complaint Files
Audit and Implementation Questions for Complaint Files
Requirements for Servicing
Audit and Implementation Questions for Servicing
Requirements for Statistical Techniques
Audit and Implementation Questions for Statistical Techniques
QUALITY UNIVERSITY mark is a registered trademark and should not be used by any individual or companies without written approval of Quality University.
Computer configuration needed for the course: - Microsoft Internet Explorer
- Make sure all Pop-Up Blockers are disabled
- For any troubleshooting, refer to Help/Support at:http://www.qualityuniversity.com/commerce/misc/onsite.jsp
- If screen is blank, exit Internet Explorer and log back in again
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: - log into Quality University through by clicking the "My Account" link
- Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
- Select your course. You may take the course and exam at your leisure.
Please follow instructions below for taking the course: - 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.
- Click on "My Courses" to see a selection of courses you have purchased that have not yet been completed
- Select your course.
You may retake the exam as many times as needed until a passing score is achieved. All courses are approved by Quality University and ISO Accelerate Group.
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 you need to reprint a certificate for any reason, visit the "My Courses" link and you will have an option to reprint a certificate for any training you have completed.
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