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Q9(R1) Quality Risk Management: Final FDA Guidance for Industry

Open Medscience

Q9(R1) Quality Risk Management provides a comprehensive framework for assessing, controlling, and mitigating pharmaceutical quality risks. The post Q9(R1) Quality Risk Management: Final FDA Guidance for Industry appeared first on Open MedScience.

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The International Council for Harmonization (ICH) Q10: A Model for a Robust Pharmaceutical Quality Management System

Open Medscience

ICH Q10 is a global model for managing pharmaceutical quality, ensuring compliance, continuous improvement, and risk manage The post The International Council for Harmonization (ICH) Q10: A Model for a Robust Pharmaceutical Quality Management System appeared first on Open MedScience.

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AuntMinnie 2007: Gadolinium: A 'necessary factor' in the development of NSF?

AuntMinnie

Making careful choices Fortunately, the imaging community has taken the old "ounce of prevention" adage to heart by proposing and adopting risk management strategies for performing gadolinium-enhanced MRI on renal patients. We smell smoke, and we're looking for the fire."

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