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Speaker Profile

Mr. Vikram Kulshreshta

Director, API & Formulation

Mr. Vikram Kulshreshta is a Senior Management Professional with experience of more than 30 years with strong Quality Assurance & Regulatory Affairs background, with a good track record in the Organizations worked for. He is an expert in “Designing & implementing the Quality Systems”, Qualifications & Validations, Trouble-shooting & CAPA implementation and Regulatory Affairs.

He is well versed with International cGMP regulations, e.g. USFDA, MHRA, TGA, ANVISA, MCC, COFFPRIS Mexico. He has conductrd Interactive workshops on QMS elements, with real life examples through interactive approach & Case studies, so as to enhance learning benchmarks for the participants. Has Registered many Drug Substances & Drug Product dossiers to US, Europe and other regions. Expert in handling Post DMF Approval changes. Consultant for - API & Formulation manufacturing companies for USFDA/EU Audit preparations, Helped the companies to get USFDA, EU & other Regulatory approvals. Conducts Pre-inspections Gap analysis & compliance.