FDA/GMP Good Laboratories Practice (GLP) 21 CFR Part 58 GLP
Implementation and Auditing for non-clinical Laboratories
Overview
This training is designed to examine the fundamentals required to understand, plan and implement an effective quality management system incorporating the FDA/GMP Good Laboratories Practice (GLP) 21 CFR Part 58 GLP for non clinical labs. Students will gain a firm understanding of the requirements for conforming, implementation and Auditing to the FDA/GMP Good Laboratories for non clinical lab.
This course has requirements, auditing questions, interpretations, and records.
There are quizzes after each module and a final exam.
What will be covered
GOOD LABORATORY PRACTICE FOR NON-CLINICAL LABORATORY STUDIES (FDA/CGMP 21 CFR Part 58 GLP)
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 article 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.
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You may retake the exam as many times as needed until a passing score is achieved.
Once you complete the course with a passing score on the exam you will be issued a certificate. Please print this certificate 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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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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