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Shimadzu has launched the World's first online TOC analyzer using mercury-free excimer lamp with our proprietary “Active-Path” designed to maximize the power of the lamp and increase oxidation efficiency. With state of the art technology enclosed in one of the smallest casing, we have managed to achieve a very high sensitivity and low detection limits, reaching 0.1 μg/L with a wide measuring range of 0 – 2,000ppb, making it perfectly suitable for ultra-pure water measurement.
The analyzer also fully complies to major pharmacopeias, such as the USP and EP while providing full security functions for FDA 21 CFR Part 11 compliance, such as user authentication and audit trail. In short, with the launch of Shimadzu TOC-1000e, customers can experience online TOC analyzer with one of the highest quality and reliability which meets all your operational requirements.
Learning Objectives:
Dr. Kapil Joshi
Head of Quality
Unichem Laboratories Limited
Having completed his studies, he has more than 25 years experience in the Pharmaceutical industry. He has vast industrial experience in terms of Quality Management, Control, Assurance, GMP & Regulatory inspections, Auditing & Regulatory Compliance, Qualification, Validations and technical transfers of Non- Sterile and Sterile finished formulations, Investigations, CAPA &Revolving regulatory Compliances, Cost Analysis & Control , Process Mapping and People Management.
Bhalchandra D. Patil
Asst. General Manager - Quality control
Hemmo Pharmaceutical Pvt. Ltd.
He has 33 years of experience in Quality Assurance and Quality Control functions of API and API intermediate industry. He is responsible for Effective Implementation of Quality System throughout the facility as well as handling Quality audits not only for Regulatory Compliance but also customer audits. He possesses thorough knowledge of cGMP, cGLP, Quality compliance & regulations. In his position, he also successfully faced regulatory audits of Indian USFDA, EDQM, KFDA, WHO GMP and various country specific drugs control authority/regulatory agency audits.
D. Mahesh
General Manager - Quality control
Human Biologicals Institute (a division of Indian Immunologicals Ltd)
Having more than 22 years of rich experience in Quality Control functions of Pharma, Bio-pharma and Vaccine industry. He is responsible for compliance of QC testing and release of Vaccines and Recombinant therapeutic Proteins. He leads QC functions in multiple locations with thorough knowledge of cGMP, cGLP, Quality compliance & regulations. He has also successfully faced regulatory audits of Indian NRA, USFDA, ISO, ANVISA, WHO GMP and various country specific drugs control authority/regulatory agency. In terms of trainings, he has attended national and international trainings by DCVMN, PATH, PDA, USP and CDSCO.
Yuichi Masuda
Product Manager - Environmental (Water analyzer)
Shimadzu Corporation, Japan