Dr. G.L. Jain
Director
Centre for Active Learning, Guidance & Solutions

He is having 26 Years of experience (2 years in chemical industry, 17 years in Biomedical Engineering, 2 years as consultant and 5 years in Medical Device industry). For last 17 years, mainly involved in medical device development, manufacturing, evaluation & standardization. He was responsible for implementation of UNFPA funded 0.8 Million-USD project ‘National Center for Technological Evaluation of IUDs and Tubal Ring’ at the Centre for Biomedical Engineering, I. I. T., New Delhi. He implemented several project of high funding especially of Ministry of Health & Family Welfare, Department of Electronics and Ministry of Social Welfare, Govt. of India.

He was instrumental in indigenous production of Copper T and Tubal Ring. (This involved utilizing training abroad for the training of industry, formulation of Indian Standard and establishing test laboratories and test protocols).

He set-up Famy Care Ltd., Goa & Corporate Channels India Pvt. Ltd., Udaipur manufacturing facilities for Copper T 200 B/380A (this involved getting building constructed as per GMP; training of staff, installation of machine, manufacturing of Copper Ts). He is having high management, planning, organizing and leadership capability. He was with USFDA for two months for training on various aspects of GMP/PMA/NDA and inspection.

He was associated with Drugs Controllerate (India) (Equivalent to USFDA) in formulating Medical Device GMP and inspection of all the Copper T & Tubal Rings manufacturing facilities existing today in India for GMP. He gained reasonable knowledge in medical device field by attending several technical courses; having regular discussions with various agencies; visiting manufacturing units; laboratories and regulatory agencies world-over.

Mr. Sanjay Y. Shah
Unikal Consultant

Mr. Sanjay.Y. Shah is in the capacity of Chief Consultant of Unikal Consultant . His experience in the professional field starts from 1975. He specializes in Consulting and Implementation of Quality management System as per ISO 9001, ISO 13485 and CE requirements as per European Council MDD/93/42 & Audits for Projects of Manufacture of Sterile Medical Devices ;Documentation & Training for various c-GMP systems including US-FDA, MCA, TGA requirements, ISO 9000 & QUALITY MANAGEMENT SYSTEM, CE CERTIFICATION, US FDA 510k, AUDIT, DOCUMENTATION AND GMP. His Collaborators for EC Services are in Brussels, EU. He serves his services to the Medical Device Industry manufacturing Products like, Sterile Single use Medical Devices, Infusion sets, Catheters & Tubes, Syringes, Intra Ocular Lenses, IUD, Coronary Stents, Engineering Items, Telecommunications & Electronics.

Dr. Hemant Desai
Deputy General Manager (Operations),
Healthcare Division,
Nirma Ltd.

Dr. Hemant Desai has done Ph.D. in Analytical Chemical & MBA, Marketing. His areas of exposure includes :

The system related to in process controls, and in house standards to achieve Consistent quality of the end product, developed documentation such as SOP, QA/QC-Operation documentations and doziers, as per the WHO standards, develop MIS (Management Information System] for strategic decision, production Planning and Material Control [PPMC], organize the productivity to the up most installed capacity to the various Department Viz - Tablets, Capsules, Oral - Liquid, [General - B-Lactum], Injectables [SVP], development & validation of clean room standards / sterility & pyrogen [LAL System], project executions from concept to commissioning, Techno-Commercial evolution / analysis of various venders [Plant machinery and RM-supplies / Manufacturers], Technical up-gradations for plant productivity by proper mapping process, Liaisoning with FDA / Government and regulatory agencies. He has done R & D on new molecules of starch derivatives for various end use industries.