Bharat Adarkar

Global Subject Matter Expert: Package Development, Validation & Technology Transfer

• MS in Materials Science & Packaging Engineering and BS in Pharmacy with over 20 years of professional experience in pharmaceuticals, medical devices and consumer products • 20 years packaging validation, PAI Readiness and Technology Transfer experience of Oral Solid Dosages, Injectables, Liquids, Ointments & Creams of pharmaceuticals & medical devices in USA, Europe and Asia • 10 years packaging development experience of medical devices, pharmaceuticals and consumer products • 5 years production operations, marketing and sales experience of pharmaceuticals and consumer products • Global Subject Matter Expert (SME) responsible for the co-ordination & approval of all packaging validation functions of existing & new Technology Transfer products for FDA & Non-FDA regulated Global Finishing Sites at Schering Plough Corporation in USA, Europe and Asia to include Pre-Approval Inspection (PAI) Readiness & Validation • Developed Packaging Validation related guidance documents, training programs and templates at Schering Plough Corporation for finishing sites in USA, Europe and Asia • Consulted for numerous pharmaceutical Fortune 500 companies in the capacity of a GMP auditor, packaging development engineer and validation specialist for Oral Solid Dosages, Injectables, Liquids, Ointments and Creams • Project Manager responsible for the development and validation of PETG and PS blisters for Medical Devices at Becton Dickinson Infusion Therapy • Validated packaging presentations for Ethylene Oxide sterilized and Cobalt-60 irradiated needles, sutures and medical devices for Ethicon, Inc. and consumer products for American Cyanamid and IC Industries • Excellent team player; Work well with management, finishing sites personnel and vendors • Willing to travel extensively as required