Welcome to Insider issue #33.
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In our first issue of 2025, Judson Russell examines crucial yet frequently overlooked aspects of FDA GMP inspection readiness for drugmakers, offering insights drawn from extensive field experience. On the device side, Jonathan Wacks breaks down the FDA's new guidance on ethylene oxide sterilization facility changes, providing essential context for manufacturers navigating this complex transition. Finally, Michel Moravia dissects a revealing warning letter that highlights systemic quality failures, offering practical guidance for maintaining robust quality systems.
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