Snehal Godse

AI in Pharmaceutical Quality Systems: From Automation to Accountability

Abstract:

Intelligent systems are moving into the core of pharmaceutical quality operations — flagging deviation patterns, predicting CAPA effectiveness, accelerating OOS/OOT trend analysis, and speeding up document review. Yet pharmaceutical manufacturing operates under GxP requirements where every decision must be traceable, defensible, and owned by a qualified human — "the model flagged it" is not an acceptable root cause in a regulatory inspection.

This talk examines the real intersection of AI and pharmaceutical quality: where intelligent systems genuinely strengthen deviation investigations, CAPA lifecycle management, and risk assessments, and where their use introduces new compliance exposure. Drawing on direct experience in GMP quality operations — deviation investigations, CAPA effectiveness, and OOS/OOT investigations— the session distinguishes documented compliance from actual inspection readiness, and outlines a practical governance framework for validating, controlling, and auditing AI tools inside a regulated quality system.

Attendees will leave with a view of what regulators currently expect from AI-assisted quality processes, and a working framework for introducing intelligent systems into GxP environments without compromising accountability.

Profile:

Snehal Godse works in the R&D department at InvaGen Pharmaceuticals, a Cipla subsidiary, where her responsibilities span MDI formulation, deviation investigations, CAPA lifecycle management, risk assessment (FMEA/FMECA), equipment qualification and validation, quality systems, and regulatory compliance within a cGMP-regulated environment. She holds an MS in Regulatory Affairs from Northeastern University and brings research experience at the intersection of scientific collaboration, regulatory compliance, quality systems, and emerging technologies. She is the author of the peer-reviewed paper "A Cross-Functional Perspective on Scientific Collaboration, Regulatory Compliance, and Quality System Integration," published in the American Journal of Technology (2026).

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