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Course Title: FDA
Software Validation for meeting FDA Requirement
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:
Purpose
Scope
Applicability
Audience
The
least burdensome approach
Regulatory requirements for software validation
Quality
system regulation vs. pre-market submissions
Context
for software validation
Definitions and terminology
Requirements and specifications
Verification and validation
IQ/OQ/PQ
Software
development as part of stems design
Software
is different from hardware
Benefits
of software validation
Design
review
Principles of software validation
Requirements
Defect
prevention
Time and
effort
Software
life cycle
Plans
Procedures
Software
validation after a change
Validation coverage
Independence of review
Flexibility and responsibility
Activities and tasks
Software
life cycle activities
Typical
tasks supporting validation
Quality
planning
Requirements
Design
Construction or coding
Testing
by the software developer
User
site testing
Maintenance and software changes
Validation of automated process equipment and quality
System
software
Validation evidence needed
Defined
user requirements
Validation of off-the-shelf software and automated equipment
FDA Software Validation for meeting FDA Requirement
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
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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