Expert Panel member
Nitin Bhatti
Enterprise Architect · AI/ML Systems · GAMP 5 · FDA Regulatory Compliance · Life Sciences track
Founder & Enterprise/Platform Architect, OrchestraPrime · Orchestra Prime
Pilot panelist
North Brunswick NJ
“I've built and validated AI systems for pharma — not just read about them. You'll leave with checklists, not theories.”
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About
Nitin Bhatti brings 26 years of IT experience, including 16 years at a top-10 global biopharmaceutical company, spanning clinical operations, manufacturing systems, and commercial pharma technology. He is the founder and enterprise architect at OrchestraPrime, where he builds AI-powered compliance and regulatory intelligence platforms for the pharmaceutical industry. Nitin has designed and deployed GAMP 5 Category 5 AI systems, built cross-site process data analytics platforms on both on-premise historians and AWS IoT SiteWise, and led enterprise system integration programs across global manufacturing networks. His courses bridge the gap between regulatory theory and real-world implementation — grounded in FDA draft AI guidance, ICH Q-series, EU Annex 22, and hands-on architecture decisions that inspectors will ask about.
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