Our products & services

Purchase Assistance

  • My Account
  • My Order

  • Online Payment System

    Course Details

    Course# QUC102
    Course Desc FDA/CGMP Training (Medical Devices) CGMP
    Your Price $175.00

    Course Overview

    New Page 1

    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

     

    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.


       
    (no title)