Ranjit Barshikar's Biography

Ranjit Barshikar, QbD/cGMP Consultant, Pharma Quality Management Consultants

In a career span of 43 years, have rich & varied experience in the Pharmaceutical Industry, especially in Quality Management, R&D, and Regulatory.cGMP Consultant / GMP Advisor to World Bank, PwC & many Indian Cos. Worked with PFIZER LTD., Ranbaxy, Lyka Labs, Cancer Research Institute Mumbai. Traveled extensively across the Globe as Chairman & or Speaker at International conferences. So far 262 presentations given in 70 countries on: “ cGMP, QbD, PAT, GCP/ GLP, 21 CFR part11, Technology Transfer, Operational Excellence , ISO, Risk Management , Vendor development /outsourcing etc.” at various International conferences organized by ISPE /FDA, Marcus-Evans, IQPC, IPC, CBI ( USA) , WHO, ISO, UNOPS, Govt. of India, CPHI , FDA of Gujarat, Maharashtra, FDA - AP, FDA - Karnataka etc. Have many articles / interviews to his credit, published in various International Journals like Pharmaceutical Manufacturing-USA, Pharmaceutical Technology-Europe, and Pharmaceutical Technology-Asia, to mention few. Have been nominated as an IPA expert for new “ICH Expert working Group on CTD QOS”. Served as member of IPA, IDMA, ISPE, Gujarat council of Bio-Technology etc.Worked also as a faculty member of OPPI, IDMA, ISO workshops & was member of “GMP committee for API” by DCGI.Was paper setter & examiner at Nasik deemed University for M.Pharm course. Was Faculty member of Bombay College of Pharmacy/KC College of Pharmacy.