JGTA Whitepaper: “Every 483 Observation Has a Training Component”
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Published on Pharmaceutical Online in June 2014, this article (listed as #4 on Pharmaceutical Online‘s top 10 most read list for 2015) describes how a comment from an FDA inspector triggers a new way to look at 483 observations to find the underlying training deficiency that led or contributed to each citing. Now available as a whitepaper!