Shikha Raikundalia

CSV Consultant
As a seasoned CSV (Computer System Validation) consultant, I bring a unique blend of expertise in biochemistry, regulatory affairs, and validation practices to the forefront of the pharmaceutical and biotech industries. With a career spanning across diverse sectors, I have consistently championed the integration of cutting-edge technologies while ensuring compliance with stringent regulatory standards.

My journey into the realm of CSV began with a foundation in Biochemistry and a Post-Grad in Biopharmaceutical Sciences. Having a solid background in clinical trials via translation of regulatory content for health authorities, I was provided with the opportunity to work for a biopharmaceutical CDMO, Genibet, providing me with a deep understanding of the intricacies of cGMP manufacturing services. Building upon this knowledge, I transitioned into a validation specialist role at Hovione, where I honed my skills as part of a multidisciplinary team validating critical systems and processes essential for drug manufacturing and quality assurance.

Recognizing the pivotal role of industry collaboration in driving excellence, I have been actively involved with ISPE (International Society for Pharmaceutical Engineering) as a volunteer and currently serve as the Chair of the GAMP (Good Automated Manufacturing Practice) Community of Practice in Portugal. In this capacity, I am dedicated to fostering knowledge exchange, best practices, and professional development opportunities for industry professionals navigating the complexities of CSV.

As a CSV consultant at Integrity, I am committed to leveraging my multifaceted background to empower organizations in achieving regulatory compliance and operational excellence. Whether navigating the validation requirements of complex IT systems or optimizing quality management processes, I am driven by a passion for innovation and a relentless pursuit of excellence in the Pharmaceutical Industry.

At the upcoming ISPE event, I look forward to sharing insights, experiences, and strategies for successful CSV implementation, and to engaging with fellow industry professionals in shaping the future of Pharmaceutical Engineering.