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SELECTBIO Conferences Quality, Compliance & Audit in Clinical Trials

J Ramniwas's Biography

J Ramniwas, CEO & Managing Consultant, Sai Pharma Solutions Inc

Mr. J.Ramniwas started his career in pharmaceuticals in 1991 and has stints in areas such as Analytical development, Validations, Qualifications, Quality Control, Quality Assurance, Documentation, Auditing, GAP Analysis, GMP & Regulatory Affairs, Training, Risk Management, Quality & Regulatory Compliance and Overall Global Quality Management and Regulatory Affairs during his career.
Since 2008 onwards he has been associated with Sai Pharma Solutions Inc (his own consulting enterprise) as the Chief Executive Officer and Managing Consultant.
He has held various positions including Vice President, President and Director of Quality
and Regulatory Affairs in Pharmaceutical Industries such as Lupin Limited, Zandu,
Zydus Cadila Healthcare Limited, Tonira Pharma Limited (IPACA laboratories),Tonira
Chemical Company Limited and Titan Laboratories Pvt Limited.
Many Pharmaceutical industries have received accreditations and approval under his leadership to name a few like US FDA, EU, EDQM, PMDA, TGA, MHRA, ASEAN,
MCC, WHO-GMP and Health Canada etc.
He has played an important role in developing, establishing Quality Systems and
Regulatory Affairs departments in various organizations. He is a trainer, speaker, writer,
visiting faculty, auditor, technical, scientific, regulatory affairs advisor and Quality Management and Regulatory Affairs Consultant for many pharmaceutical industries. His consulting enterprise SAI PHARMA SOLUTIONS INC is the “Gateway for Quality, GMP and Regulatory Compliance” solutions.
Under the aegis of Sai Pharma Solutions Inc Mr. J.Ramniwas has undertaken the projects of auditing, training, documentation, regulatory submissions, regulatory compliance, regulatory remediation, quality compliance, QMS development, risk assessment, data integrity, GXP support, technical and scientific advisory support, facility design inputs, validations & qualifications and technology transfer for API, Drug Product, KSM, Excipient, Medical device, packaging material, cosmetic, ayurvedic and herbal product manufacturers, CROs and Quality Control Laboratories. All projects undertaken by him are completed successfully within the stipulated time. He is also the current vice
president of Indian Pharmaceutical Association, Vadodara Branch.

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GCP/GLP & Other Requirements for CT/BE Studies

Friday, 13 April 2018 at 12:05

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