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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.
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
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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