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A significant number of 483’s and Warning Letters related to the stability function is proof that not all companies have an adequate program in place. Since regulatory requirements and guidance’s provide only a general picture of expectations for stability programs, much interpretation is left up to individual companies. A better understanding of regulatory expectations and careful preparation is warranted to avoid joining those organizations receiving stability citations.

This accredited online training will cover all aspects of preparing for and conducting/hosting an audit of the medical product stability function.

Course Instructor:  John O’Neill

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