Proflie: He is a qualified Quality Assurance professional with 22 years of work experience working in US, European and Indian pharmaceutical industry. His specialties include: GCP audits (lead more than 300 audits of Clinical investigator sites, TMFs, study documents and third party vendors (including Clinical laboratories, CROs, Drug depots, Phase I Units, Bioequivalence/Bioavailability Units (including Bio-analytical labs), Translators and Ethics Committees), Pharmacovigilance system audits,Data Management audits (including clinical database audits and process audits),Statistical programming and Clinical Study reports audits,Computer System Validation audits,Developing and implementing risk based Quality System plans ,Inspection readiness planning and conducting mock inspections,Handling serious quality issues, leading for cause investigation, Root cause analysis and CAPA management,SOP development,Customized GCP training and auditors’ skill development audits. . Countries Covered: audits in India, Australia, China, France, Georgia, Greece, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, South Africa, South Korea, Taiwan, Thailand, UAE, United Kingdom and Vietnam. Current City: Mumbai. Language Expertise: English, Hindi.