Ranjit Barshikar has 51 years of Pharmaceutical / Biotechnology Industry Experience in Quality, R&D, Mfg., and Regulatory. He is
experienced in Quality Systems, Manufacturing Excellence, and the US and Foreign GMP Compliance. He being a QbD expert, has
trained more than 1500 Scientists from Global Multinational & Generic Cos., on QbD implementation & ANDA filings for QbD elements.
He has significant experience in Compliance and Quality Management, Validation, and GMP compliance auditing of manufacturing facilities for the production of sterile products by aseptic processing, solid dosage forms, etc. Additionally, Mr. Ranjit has high experience in ICH Q11-QbD implementation in API development, ICH Q14-Analytical Method Development by QbD & Validation, ICH Q12- Life Cycle Management. He has several articles published Globally on cGMP Compliances / QbD implementation. Mr. Ranjit is specialized in Process Analytical Technology (PAT) Process monitoring.
