Title : Inspection Readiness: Continuous Quality Mindset

Inspection readiness cannot be treated as a project or a last?minute clean?up effort; it must be a continuous quality mindset integrated into daily operations. This presentation proposes a practical operating model that embeds inspection readiness into routine behaviors, systems, and governance. The approach centers on three pillars: (1) Daily Discipline, ensuring that documentation, data integrity practices, deviation management, and equipment oversight are always “audit?ready”; (2) Tiered Governance, enabling cross?functional review of quality signals, metrics, open investigations, and CAPAs to detect issues before they escalate; and (3) Scenario?Based Preparedness, incorporating mock inspections, playbooks, and targeted training to build confidence and fluency in inspection roles. Participants will learn how to implement inspection readiness huddles, improve response structures using the “Listen–Acknowledge–Answer–Stop” model, and use risk?based prioritization to close gaps efficiently. The session also discusses common pitfalls such as reactive clean?up behaviors, siloed communication, and inconsistent narratives during inspections. Examples demonstrate how organizations that adopt a continuous readiness model achieve faster responses to regulators, fewer inspection observations, and stronger overall QMS maturity. Attendees will leave with a repeatable roadmap for building inspection?ready behaviors without increasing workload—driving a sustainable culture of quality and compliance.

Sushant Kulkarni is a Senior Manager, QA Operations, at clinical stage biotechnology company and is specializing in GMP compliance, deviation investigations, and supplier quality systems. He has reviewed manuscripts for Molecular Therapy and ASQ’s Quality Progress, and serves on the 2026 National Biotechnology Conference Abstract Screening Committee. Sushant’s work focuses on risk based qualification, inspection readiness, and data driven CAPA effectiveness. He has led cross functional quality initiatives that streamline decision making and strengthen compliance without adding complexity. He presents in a personal capacity; views are his own.