Satya Grandhi is a seasoned professional currently serving as a Senior Validation Engineer at AM Logic Corporation, where he leverages over a decade of industrial experience in Computer System Validation (CSV), equipment, and process validation across the Manufacturing, Pharmaceutical, and Bio/Clinical Lab sectors. His profound...
Satya Grandhi is a seasoned professional currently serving as a Senior Validation Engineer at AM Logic Corporation, where he leverages over a decade of industrial experience in Computer System Validation (CSV), equipment, and process validation across the Manufacturing, Pharmaceutical, and Bio/Clinical Lab sectors. His profound expertise in regulatory compliance, particularly with US FDA regulations such as 21 CFR Parts 11, 58, 210, 211, and 820, positions him as a key player in ensuring that AM Logic's products meet stringent quality and safety standards.
In his current role, Satya is instrumental in leading critical validation projects that enhance the integrity and reliability of manufacturing processes. A notable project involved conducting a comprehensive data integrity audit, which identified gaps in Good Manufacturing Practices (GMP) and Part 11 compliance for a key product's manufacturing equipment. Satya spearheaded the remediation efforts, implementing robust solutions to address these gaps and conducting thorough analyses to prevent future discrepancies. His proactive approach not only mitigated compliance risks but also reinforced the company's commitment to quality assurance.
Satya's skill set encompasses a wide range of validation methodologies, including Software Development Life Cycle (SDLC) practices, GAMP (Good Automated Manufacturing Practice) guidelines, and Cleaning Validation protocols. His dedication to continuous improvement and regulatory adherence has made him a trusted resource within the organization, fostering a culture of quality and compliance. As AM Logic Corporation navigates the complexities of the pharmaceutical landscape, Satya's insights and leadership in validation processes are invaluable in driving operational excellence and ensuring product integrity.
