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Course Title: FDA-GMP
Good Lab Practice for nonclinical (21 CFR part58) Implementation and Auditing
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:
General
provisions
Scope
Definitions
Applicability to studies performed under grants and contracts
Inspection of a testing facility
Organization and personnel
Personnel
Testing
facility management
Study
director
Quality
assurance unit
Facilities
General
Animal
care facilities
Animal
supply facilities
Facilities for handling test and control articles
Laboratory
Operation areas
Specimen
and data storage facilities
Equipment
Equipment design
Maintenance and calibration of equipment
Testing
facilities operation
Standard
operating procedures
Reagents
and solutions
Animal
care
Test and
control articles
Test and
control article characterization
Test and
control handling
Mixtures
of articles with carriers
Protocol
for and conduct of a non-clinical laboratory study
Protocol
Conduct
of a non-clinical laboratory study
Records
and reports
Reporting of non-clinical laboratory study results
Storage
and retrieval of records and data
Retention of records
Disqualification of testing facilities
Purpose
Grounds
for disqualification
Notice
of and opportunity for hearing on proposed disqualification
Final
order on disqualification
Actions
upon disqualification
Public
disclosure of information regarding disqualification
Alternative or additional actions to disqualification
Suspension or termination of a testing facility by a sponsor
Reinstatement of a disqualified testing facility
FDA-GMP Good Lab Practice for nonclinical (21 CFR part58)
Implementation and Auditing 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
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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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