| Abstract ||We are delighted to announce our 3rd Annual International conference “QbD in Pharma Development World Congress 2015” with the theme "Emerging Challenges, Federal Issues & Possible Solutions" scheduled to be held on April 16-18, 2015 in Hotel Shivalik View, Chandigarh, India. This year the event has been planned so as to bring together the experts from across the globe making it a mega event.|
The federal agencies have reiterated to build quality into the products during multi-phase product development life cycle and eventually, enhance product and/or process understanding, all using the rational and systematic QbD. The key elements of QbD, including the QTPP, CQAs, QRM, CMA, CPP and control strategy, as enumerated in the ICH guidelines viz. Q8, Q9, Q10 and Q11, are being followed and QbD paradigms implemented in several pharmaceutical companies. Nevertheless, much water has flown in the Ganges and Amazon since the proclamation of QbD guidance by the ICH, and subsequent endorsement by US FDA, EMEA, EGA, MHRA and so on. The acute need of the hour today is to address these issues, meet these challenges and provide custom tailored solutions to the problems which the scientists in pharmaceutical industry are currently facing during QbD implementation. Rather than dealing with scattered thoughts, this conference would endeavour to provide a comprehensive one-stop platform to deal with the disparate vistas catering to the scientists in industry and research.
| Topics ||Analytical QbD, Design of Experiments, Design Strategies for Dissolutions, Bioequivalence & Stability, Federal Perspectives & Issues, Formulation by Design, Multivariate Chemometric Tools, PAT and RTRT tools, QbD and QbR, QbD in API Manufacturing Process, QbD in Product Life Cycle, QbD Perspectives in Biologicals, Risk Estimation Monitoring|