December 11 – 13, 2014
Registration deadline: December 3
In order to share knowledge and ideas regarding application and implementation of Quality by Design in pharmaceutical manufacturing, analysis, testing and clinical trials, Institute of Pharmacy, a constituent of Nirma University, Ahmedabad will host a seminar on QbD.
The current scenario of pharmaceutical field demands knowledge regarding QbD approach. Recently, QbD has become an axiom in the pharma sector. USFDA has made use of QbD mandatory for generic manufacturing from January, 2013. The regulatory agencies are making it mandatory to build quality into the products during the product development stage itself.
The new quality mantra is "The quality should be built into, rather than tested into the finished product". The key elements of QbD include the QTPP, CQAs, QRM, design space, control strategy and continuous improvement, as enumerated in the ICH guidelines, Q8, Q9, Q10 and Q11. Many regulatory agencies across the globe like US FDA, Health Canada, WHO, EMEA, TGA, MHA etc. have already adopted these ICH guidelines.
Apart from this, QbD is also emerging as an important tool for fastening the time for reaching the market, reducing the recalls and rejects, minimizing post-approval changes, and improving the overall safety and efficacy of the product. The objective of the present seminar is to provide a platform for sharing the knowledge and ideas regarding application and implementation of QbD in pharmaceutical manufacturing, analysis, testing and clinical trials. The seminar features expert lectures from different disciplines of pharmacy which will provide and opportunities to the young scientist and research scholars for interactions.