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| Is it worth the effort to become a GLP laboratory? |
| A common problem/issue among university and small laboratories that want to participate in regulated studies is that most are not up to Good Laboratory Practice (GLP) standards. GLPs are regulated by the FDA and the EPA to help assure the quality and integrity of studies submitted to these agencies. Is it worth the effort to become a GLP lab? |
| If you are involved with any part of a non-clinical study for a drug, device or food ingredient that will be submitted to the FDA, 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. |
View Upcoming Course Dates
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| Our One-Day Seminar |
| In this one-day seminar, you will learn GLP principles and what it takes to get a laboratory in compliance with Good Laboratory Practices. This is not a GLP training course; GLP training is offered separately. This course is specifically designed for anyone who wants a better understanding of the GLPs and especially for companies, individuals or universities examining the feasibility of entering regulatory research. This course is also important for personnel from laboratories where management has decided that they will not go through the effort be GLP compliant, and why it is imperative for personnel and management to never imply that they are a GLP laboratory. |
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| Have you or anyone you know ever run into either of these situations? |
- You have a unique specialty. Your lab has developed an analysis/technique that you would like to conduct for pharmaceutical or food ingredient manufacturers so that they can use those data for the development of their product and approval by the FDA. Performing this type of research can bring in funding for the lab as well as publications for professors and students. Then the bomb drops: they ask you if your laboratory follows GLPs. You lose the project because your lab is not GLP compliant.
- You won a large grant from a company that is trying to get a product approved by the FDA. You have done research and generated critical data to support their indication. The regulatory application is filed using your data. The data are rejected by the FDA because your laboratory was not up to GLP standards. The entire project was put on hold and the company now suffers a major setback.
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| This course will help you decide if setting up a GLP laboratory is right for you. |
| After the course is completed, you will be able to make an informed decision about the future status of your laboratory. You will be able to determine if the academic and financial rewards are worth the effort to comply with GLPs. |
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| Who Will Benefit? |
- Universities
- Professors
- Graduate students
- Undergraduate students conducting research
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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 30 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 8 years. |
| Costs |
$725 per attendee.
A $25.00 early bird discount will apply for registrations and payments received three or more weeks prior to the start of the course. |
| There is a further 5% discount for two or more attendees from the same company/university (attendees from the same facility must register at the same time). Call for further discounts for 10 or more attendees. |
| The cost for the course includes morning
and afternoon breaks, lunch, and handouts. This course will start
at 9:00 and end at approximately 4:00. Registration starts at 8:30.
Dress is business casual. |
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