ICH Q10 - Quality Systems - Nov 27, 2006

Joseph Famulare, FDA's Acting Deputy Director at the Office of Compliance of CDER, recently gave a presentation on the newly proposed ICH guideline on Quality Systems, known as Q10.

This guideline will describe a model for an effective Quality System needed to establish and maintain a state of control that can ensure the realization of a quality drug product and facilitate continual improvement over the product life cycle.

ICH is the International Conference on Harmonization
CDER is the FDA Center for Drug Evaluation and Research

You can download the presentation at
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources

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