Biotech Webinar 2011 - Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products

Why Should You Attend:

cGMP guide lines were formulated for the purpose of regulating large-scale manufacturing and commercial drug products. But it is amended in 21 CFR Part 210 for applicability to small-scale laboratory production of exploratory and investigational drug and biologic products. The amended GMP guide lines are a component of the FDA’s “Product Quality for the 21st Century” initiative for a selective approach to varying production objectives during drug development. These exemptions allow the option to the FDA to advise investigators on the safety requirements of laboratory production lots that unequivocally permit administration to human subjects in clinical trials.

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