Course Title: FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation

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.

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

FDA CGMP Final Exam for Medical Devices, Auditing/ Auditor/Implementation

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.

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• 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

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http://www.qualityuniversity.com/commerce/misc/other.jsp

• 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

• 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.