2013 AM: DD-1 - Landmark Cases in GLP

2013 AM: DD-1 - Landmark Cases in GLP
DD-1 - Landmark Cases in GLP

Wednesday, 1 May 2013

Jim McCormack, IBM, Armonk, New York, USA

For individuals beginning a quality assurance (QA) career in nonclinical safety assessment the FDA Good Laboratory Practice (GLP) may sometimes seem complex and onerous. It is essential that new QA professionals understand why the GLP regulations were promulgated and what concerns they were intended to address. To that end, this presentation will review the history of safety assessment under the Federal Food, Drug, and Cosmetic Act and the events and investigations that lead the development of the GLP regulations. The investigations of G. D. Searle and Company, Industrial Bio-Test, and Biometric testing will be presented. The presentation will demonstrate how the provisions of the GLP regulations relate to the findings from these investigations and discuss the significant public health implications of poor quality or fraudulent safety studies.

Session Length: 63 minutes
Discounted member price: 10.00
20.00
You could save: 50%

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