GOOD LABORATORY PRACTICE REGULATIONS (GLP)
This seminar is on the Good Laboratory Practice (GLP) Regulations of the Food and Drug Administration (FDA), which are necessary for Non-Clinical Laboratory Studies. These regulations must be complied with for those businesses involved in these activities.
On completion of this seminar, you will learn:
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FDA’s Good Laboratory Practices (GLP) requirements |
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Compliance benefits with GLP |
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The consequences of not complying with GLP |
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How to implement the GLP efficiently and effectively |
Verifying you have a healthy system by internal auditing and applying a strong corrective and preventive action (CA/PA) system. The course also covers how implementing GLP makes good business sense and the conditions under which the testing facilities can be disqualified.
Who should attend this seminar?
Managers, study directors, operators and quality assurance personnel who are involved in laboratory operations. It is also valuable for personnel who are involved in auditing for GLP Regulations. Up to 24 persons may participate in this seminar. It will require 8 hours of class time including that for team activities. All materials win be provided. At the successful completion of the seminar a certificate will be awarded.
Topics covered:
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Similarities and Differences between GLP and GMP |
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General Provisions of GLP |
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Organization and Personnel |
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Facilities |
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Equipment |
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Operation of Testing Facilities |
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Test and Control Articles |
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Protocol for conducting a Non-clinical Laboratory Study |
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Records and Reports |
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How and when a Testing Facility can be disqualified |