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| Good
Laboratory Practice Training Refresher Course |
| If you are involved with any part of a non-clinical study for a drug, device, food ingredient, or tobacco product, you need to be aware of what the FDA expects from you, or your data may not be considered in the application. Deficiencies in laboratory quality systems can prompt FDA enforcement actions that may go beyond a warning letter. |
In this half-day seminar, we will review the basic requirements
of the Good Laboratory Practice (GLP) regulations as set forth
by the Environmental Protection Agency (EPA) and the Food and Drug
Administration (FDA), and OECD guidelines, understand GLP compliance and to be able to recognize
non-GLP compliant situations, as presented.
This course is structured to be interactive, and will include
plenty of opportunities for questions and discussions. This course is also
a good introduction to Good Laboratory Practices for Information Technology
(IT), Engineering, Maintenance, Pest Control and other personnel
who may be directly or indirectly working with a GLP facility. |
| Certificates of completion for the employee’s training file will be awarded to the attendees after successful completion of the course. |
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| Who Will Benefit? |
- Laboratory staff, management and quality assurance personnel
- Study Directors
- Sponsor Monitors and Sponsor Representatives
- Animal care personnel
- IT personnel
- Maintenance and Engineering personnel
- Anyone with prior GLP Training who needs refresher training
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| Your Instructor |
Robin Guy is
a board certified toxicologist, a certified GLP Professional
(RQAP-GLP) and principal of Robin Guy Consulting, LLC.
She
has over 35 years of experience preparing, conducting
and monitoring GLP studies in addition to performing
GLP facilities audits. Robin has been conducting GLP
training courses for over 16 years. |
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