Ajit Basrur, is owner of Claritas Consulting, LLC which provides Pharmaceutical, Medical device, Laboratories, and Cosmetics organizations with quality system compliance (including training), internal audits and supplier audits, to meet their customer, ISO and regulatory requirements. Prior to this role, Ajit has been in the regulated industry for 30 years serving in quality and production roles, and has demonstrated proven leadership in various elements of quality management systems (cGMP, GLP and regulatory requirements), audit and compliance, root cause analysis, problem solving and CAPA, change management, investigations, qualification and validation, quality tools and various aspects of regulatory affairs.

Ajit is a Certified Biomedical Auditor (ASQ CBA) and Certified Pharmaceutical GMP Professional (CPGP) and is well-versed with numerous standards and guidelines including but not limited to ISO 9001, ISO 13485, ISO 14644, ISO 14971, 21 CFR Part 4, 21 CFR Parts 210/211 and 21 CFR Part 820, ICH Q7, Q8, Q9, Q10, Q11, IPEC Excipient GMPs, ISO 11135, ISO 11137, ISO 14971, Gap analysis and quality system remediation, Internal audits, Supplier audits, and FDA Mock Audits.

Ajit holds a degree in Microbiology and has a global experience by working in India, China, Hong Kong, Singapore and USA.