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Ajit Basrur

Ajit Basrur is an experienced quality professional in Pharmaceutical and Medical Devices with over 30 years of experience in global compliance. He is a certified Lead Auditor in ISO 9001 and ISO 13485 and ASQ CBA. Ajit has vast experience in quality system elements of 21 CFR Part 820, 21 CFR Parts 210 and 211, ISO 13485, ISO 9001, European Medical Device Directive (93/42/EEC), Japanese MHLW 169 and Canadian Medical Devices Regulation (SOR/98-282). His expertise is in audits, compliance, quality system remediation, and establishing quality systems to meet regulatory and customer expectations He has a strong track record of success in remediation efforts driving effective results in difficult situations on a global basis.

He holds a degree in Microbiology and has a rich global experience by working in India, China, Hong Kong, Singapore and US. He was the Forum Administrator at where he moderated sections on pharmaceuticals and medical devices. He is a member of ASQ, ISPE and RAPS. He has recently started his own consulting company called Claritas Consulting and working on different projects.

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