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.

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• 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.