GLP training for sponsors
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.
 
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.
View Upcoming Course Dates
 
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 OECD and Food and Drug Administration (FDA), understand GLP compliance and be able to recognize non-GLP compliant situations. Responsibilities of Sponsors will be discussed in detail. 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!
 
  Who Will Benefit?
  • Sponsors
  • Sponsor’s monitors
  • Management
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.

Overview | GLP Training Course | Refresher Course
Training for Sponsors | University & Small Lab Primer
Training for Analytical-type Labs | Training for Trainers
Customized Courses | Training Modules
 
Robin Guy Consulting LLC's Home Page