Good Laboratory Practice for Nonclinical Laboratory Studies

AVAILABLE ON-DEMAND

Duration: 90 Minutes

Course Instructor

Lucia Mokres

Accreditation

0.2 CEUs

IACET

Price

$ 195

Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Complying with the principles of Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) is of utmost importance to ensure the reliability and credibility of study data. Nonclinical laboratory studies, also known as preclinical studies, play a vital role as a prerequisite for demonstrating the safety and essential performance aspects of products intended for human use.

In this accredited course, we will delve into the origins of GLP, thoroughly examine its key components, and present insightful case studies that allow participants to analyze and develop strategies for addressing GLP-related situations that may arise within their organizations. Furthermore, we will explore the circumstances under which non-GLP studies may be deemed appropriate, providing participants with a comprehensive understanding of when alternative approaches can be considered.

Upon completion of this course, you will be able to:

Recount the origin of Good Laboratory Practice and where to find current guidance
List the 9 major sections of the FDA GLP regulation and describe key elements of each
Evaluate case studies pertaining to GLP and consider what you would have done differently
Determine when non-GLP studies might be appropriate

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Who should
attend?

LEVEL

Introductory

INTERESTS

Biotechnology / Biopharmaceutical Medical Devices / Diagnostics Pharmaceutical Science & Technology Preclinical / Non-Clinical

This course is intended for all industries developing products that require FDA approval for research or marketing including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.

It will be beneficial to anyone planning, conducting, monitoring, managing, supervising, or otherwise supporting non-clinical studies.

This program is especially valuable for onboarding any employee involved directly or indirectly in nonclinical study planning and execution, to ensure alignment on GLP culture and fundamentals within your organization prior to engaging in work that impacts GLP compliance.

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

Learn more