GXP

Environmental Excursions and Drug Product Stability

Regulatory 101 will discuss relevant and practical questions faced by quality and compliance managers that require regulatory perspective. Topics such as regulatory inspections, FDA-483s and Warning Letters, GMP manufacturing compliance topics, product technical management, and related topics are planned for discussion -- all of which are supportive to the work of the quality and compliance function. These general topics were suggested by quality managers at various national and international meetings. Regulatory 101 will be successful if our readers participate in its development. Suggestions...

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