The following Training Programmes were organised from CII IQ during July, August & September 2007Pharmaceutical Training by International Experts As part of the CII Institute of Quality initiative to usher high-ended international quality training programmes in the Pharma/Biotech sector for Skill building , 4 international experts were invited to train the Indian Pharma Industry.5 training programmes were conducted across India. Dr Thomas Colonna and Mr Stuart Green from the USA, Dr Jean Paul Desylpere from Singapore and Dr Kiran Marthak from UK/India were the four faculty members who conducted these In-house as well as Open programmes. This was the first time initiative of the CII Institute of Quality which was greatly appreciated by the Indian Industry with the next set of programmes slated for December 2007. The programme wise details are as follows: Design Control, Software Validation & Safety Risk Management 6-7 August, 2007, Jubilant Organosys, Mysore Faculty: Dr Thomas Colonna and Mr Stuart Green 30 participants 30 participants underwent an understanding of the Design Control, Software Validation & Safety Risk Management for pharmaceutical and biotech products; Guidelines for regulatory documentation and Strategies to avoid common problems. Participants also received a course book that would serve as a future reference. Course Description This course covers current FDA regulatory compliance with respect to developing Pharma & Biotech products. A focus was placed on basic regulation and the FDA’s supplemental guidelines. Through lectures, discussions, and exercises participants learnt the context of design control within the overall quality system and regulation, HACCP (Hazard Analysis and Critical Control Points), design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies and strategies for integrating general quality system procedures into design control. Training in International GMPs: Complying with Requirement in the U.S., EU and Japan 9-10 August, Shasun Pharma, Chennai Faculty: Dr Thomas Colonna and Mr Stuart Green 26 participants |