|
|
 |
 |
 |
| Good Laboratory Practice Training |
| 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 one-day seminar, you will learn/review the requirements of the Good Laboratory Practice (GLP) regulations as set forth by the Environmental Protection Agency (EPA)
and the Food and Drug Administration (FDA), in additon to the OECD guidelines. You will learn about GLP compliance and to be able to recognize non-GLP compliant situations as presented. Responsibilities of personnel, the study director, sponsors, management, and the Quality Assurance Unit (QAU) will be discussed. This course is structured to be interactive, and will include plenty of opportunities for questions and discussions. |
| The course will be supplemented with open discussions and workshops along with interactive time to discuss individual attendee's issues. |
| Certificates of completion for the employee’s training file will be awarded to the attendees after successful completion of the course. |
| |
| Who Will Benefit? |
- Laboratory staff, management and quality assurance personnel
- Study Directors
- Sponsor Monitors and Sponsor Representative
- Animal care personnel
- University employees
- Graduate and undergraduate students conducting research
|
| 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. |
| |
| |
|
|
|