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By definition of the GLPs, a Sponsor is: A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study; A person who submits a nonclinical study to the FDA in support of an application for a research or marketing permit; or a testing facility, if it both initiates and actually conducts the study.
In other words – Sponsors have GLP responsibilities! |
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| If you or your company are planning a submission to the FDA and have conducted or will conduct non-clinical studies for a drug, device or food ingredient, you need to be aware that you are legally responsible for that submission. |
| Part of this responsibility includes being aware of GLPs and how they can impact a submission. There may be cases where a Sponsor may not have their own laboratory, and may not be trained in GLPs due to that reason. Be aware though, that Sponsors still need to follow the GLP mandate. The Sponsor has GLP responsibilities; no matter if they are conducting laboratory studies themselves or outsourcing part or all of their preclinical (nonclinical) laboratory studies. |
| Failure to follow the GLPs can prompt the FDA to take action, including placing your submission on clinical hold or refuse to accept certain studies. |
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| Our One-Day Seminar |
In this one-day seminar, you will learn/review the requirements of the Good Laboratory Practice (GLP) regulations as set forth by the Food and Drug Administration (FDA), and touching on the OECD guidelines, in addition to understand GLP compliance and be able to recognize non-GLP compliant situations, as presented.
Responsibilities of Sponsors will be discussed in detail, including possible changes as proposed by the FDA.
This course is structured to be interactive, and will include plenty of opportunities for questions and discussions. |
| Certificates of completion for the employee’s training file will be awarded to the attendees after successful completion of the course. Don’t have a training file? Part of this course will focus on why you should have a training file! |
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| Who Will Benefit? |
- Sponsors
- Sponsor’s monitors
- Management
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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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