Blog Post
Beyond Batch Testing: What FDA’s Draft Guidance on 21 CFR 211.110 Signals for the Future of Pharmaceutical Manufacturing
How evolving inspection expectations, digital manufacturing, and AI-enabled quality systems are reshaping pharmaceutical control strategies. For many pharmaceutical organizations, the FDA’s draft guidance on Considerations for Complying with 21...
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Blog Post
Engaging Early: FDA’s Collaborative Pathways for AI in Regulatory Applications (Part 3 of 3)
Nick Armstrong, Senior Director of Digital Enablement at CAI and co-chair of the ISPE Community of Practice on AI, specializes in the intersection of artificial...
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