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3.00 RAC

Good Laboratory Practice (GLP)

This course provides an overview of GLP regulations as they are applied and interpreted by the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the Organization for Economic Cooperation and Development (OECD). It covers how GLPs fit into a quality system, what types of studies are covered and how GLPs in the US and international market align.

3.00 RAC

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Good Laboratory Practices (GLPs) are the minimum standards for the proper conduct of safety testing in a nonclinical environment. They contain principles for managing and operating laboratory testing facilities involved in the early development of new chemicals and substances that may possess...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design