Claritas Consulting, LLC offers specialized Quality and Regulatory Consulting for Pharmaceutical, Medical Device, Laboratories, and Cosmetics organizations.
Ajit Basrur, Manager, is ASQ Certified Medical Device Auditor (CMDA), ASQ Certified Pharmaceutical GMP Professional (CPGP), ASQ Certified Supplier Quality Professional (CSQP), ISO 9001 Certified Lead Auditor, and ISO 13485 Certified Lead Auditor. Ajit has proven experience in 21 CFR Part 820, 21 CFR Parts 210 and 211, ISO 13485, ISO 9001, European Regulations, Japanese Regulations, Canadian Medical Devices Regulation, ISO/IEC 17025, Good Distribution Practices and EFfCI requirements.
With a vast experience, we provide customized and value-added solutions to build a quality system that minimizes regulatory risk and maximizes compliance to meet regulatory and customer expectations. The expertise includes internal audits, supplier audits, quality system remediation, regulatory guidance, Root Cause Analysis and CAPA, investigations, qualification and validation, environment controls, cGMP elements and establishing quality systems. Ajit is adept in influencing individuals and organizations, demonstrating superior communication and mentoring skills, and has a strong track record of success in remediation efforts driving effective results in difficult situations on a global basis.
Ajit holds a degree in Microbiology and has a global experience working in India, China, Hong Kong, Singapore and United States. He is a member of ASQ, ISPE and RAPS. He is also a Forum Administrator at Elsmar Cove.