Articles by Victoria Lander - BioPharm International

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Articles by Victoria Lander

Victoria Lander


21 CFR Part 11: Choosing a Risk Assessment Methodology
February 15, 2004

The FDAs risk-based approach to pharmaceutical cGMPs applies to 21 CFR Part 11 enforcement as well. Understanding different methodologies for assessing and managing risk will help you develop and begin to implement a compliance plan.

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