Bioinformatics Institute of India: Pharma Department

Quality by Design seminars in Mumbai & Hyderabad

International Business Conferences (IBC) will be organizing two Quality by Design (QbD) seminars in Mumbai and Hyderabad respectively. In Mumbai ,the seminar will be held at Le Royal Meridian Hotel from March 8 to 10 and in Hyderabad from March 10 to 12.The speakers at the seminar include Dr Line Lundsberg, Senior Consultant, Quality by Design , Lundsberg Consulting, UK and Dhaval Trivedi, Asst Manager , Regulatory Affairs , Intas Bio pharmaceuticals.

Line Lundsberg PhD (Experimental Physics) is a scientist with many years practical experience in the pharma industry. She is one of the pioneers in PAT and QbD. She now works as an Independent Consultant and is an internal consultant for NNE Pharmaplan. She is also membership secretary of ASTM E55. Dhaval Trivedi is a regulatory affairs professional with experience of biosimilar product development. Currently he is leading regulated market and domestic market submissions. He has played a key role in preparation and submission of marketing authorisation applications with special focus on CMC.He is an M.Tech.in bioprocess technology from the University Institute of Chemical Technology.

 The QbD course will be focusing on : framework for QbD,1CHQ8/Q9/Q10/Q11, key concepts of QbD including practical understanding of CQAs, CPPs, material attributes, design space arid control strategy, Real Time Release,brief introduction to QbD enabling tools, pharmaceutical quality system,how the outcome of QbD can be used lor making qualification and validation easier and more efficient,science and risk based verification,practical examples and exercises,introduction and understanding of key elements of QbD, biopharrna product development,practical understanding for implementation of tools of QbD,various methodologies of risk analysis,DOE practical understanding with case study,design space creation,regulatory expectations and QbD.