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Quality Systems No Longer Theoretical as Industry Begins Implementing Concepts

This article was originally published in The Gold Sheet

Executive Summary

Alignment of reality with ICH quality systems theory is under way. Industry is developing, promoting and implementing global solutions through ISPE's new PQLI process, with the involvement of regional regulators. Conformia's new, more complex mock P2 could kindle more QbD. Genentech's approach to QbD described in detail. Quality systems seen as an option you can't refuse. Lessons from the device sector. Why Lilly switched to quality systems and how it benefited. How Abbott prepares for the future with management reviews. What Amgen did to correct its CAPA process - and save millions of dollars along the way

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