When Kishore began his career more than 25 years ago, commissioning and validation was just gaining traction. The level of detail required to design, build, commission, and start-up a facility in the life sciences industry was complex. As new technologies and equipment continue to emerge, Kishore stays current with industry standards so he can deliver creative solutions that will help clients meet their goals both from a business standpoint and from regulatory expectations.
Kishore is passionate about learning and shares that knowledge of best practices and industry standards with clients. He finds great satisfaction in working in the field and collaborating with clients who manufacture a broad range of drug products.
In today’s market, there’s an increased focus on automated processes and risk based approaches in the design and manufacture of drug products. Regulatory bodies expect that drug manufacturers and their suppliers fully understand their processes, critical parameters of production, and inherent risks to personnel and consumers. Kishore’s work is critical in assisting clients meet these regulatory requirements, produce safe and effective drug products for humans and animals, as well as meet their business goals.
He has led teams of specialists to execute numerous commissioning and qualification projects involving R&D facilities, parenterals, oral solid dosage, and potent compound processes in the pharmaceutical industry. Kishore has significant knowledge of the coordination required in the commissioning and validation process, and has worked extensively with the client's engineering, technical services, and quality departments.?