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Subrat SaurabhAuthor of Kuch Woh Pal
Artificial Intelligence for Pharmaceutical Audit Survival is a practical guide to navigating modern regulatory inspections with confidence. It explores how AI can streamline compliance, enhance data integrity, and predict audit risks before they arise. The book bridges the gap between traditional GxP practices and next-generation digital tools. With real-world insights and use cases, it empowers pharma professionals to stay audit-ready at all times. A must-read for organizations aiming to transform compliance into a strategic advantage.
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Amit Kumar Guru
Amit Kumar Guru is a senior pharmaceutical quality and compliance professional with over two and a half decades of hands-on experience across regulated drug manufacturing, global regulatory inspections, and enterprise quality systems. His career spans the full pharmaceutical product lifecycle, including R&D, manufacturing, quality control, quality assurance, validation, and regulatory compliance, with direct exposure to both innovator and generic environments. He has worked extensively within highly regulated GxP frameworks, supporting organizations through US FDA, EMA, MHRA, WHO, MCC, TGA, HPFB, PMDA, and other international regulatory inspections.
He has worked with various organizations like Ranbaxy Lab Ltd, Cipla Ltd, Merck KgA, Macleods Pharma, Strides Arcolab, Daichi Sankyo, Sunpharma, Sparta Systems, Honeywell, and Connexo Co. Ltd. His experience includes leadership roles in electronic Quality Management Systems (eQMS), computerized system validation (CSV), data integrity remediation, and global quality harmonization programs.
Amit Kumar Guru is a strong advocate for human-centered, risk-based AI adoption, emphasizing transparency, explainability, and regulatory accountability. He regularly advises leadership teams on AI governance models, validation strategies, and cultural readiness, helping organizations transition from traditional compliance models to future-ready, digitally enabled quality systems. His focus is on pragmatic, regulator-aligned compliance and responsible adoption of AI and advanced analytics in pharmaceutical environments.
