Video

Breaking Free from 20 Years of 'Do Everything' Mentality

Source: Clinical Leader

Joe Fitzgerald of Regeneron provides historical context for the regulatory evolution from ICH E6's original focus on thorough, consistent execution to the current emphasis on QbD. He explains how the industry is shifting from 100% SDV and exhaustive edit checks to early detection and prevention of high-impact errors, emphasizing the mindset change required for successful implementation.

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