QbD in Pharma Development World Congress 2015

SELECTBIO is organizing the 3^rd Annual International QbD 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. Over 150 scientists from India and abroad and from Industry and academics are expected to attend the event. With Professor Bhupinder Singh Bhoop, Chairperson, UIPS, Panjab University, Chandigarh serving as Conference Chair, this event will provide an excellent platform for researchers from all facets of drug research an unprecedented opportunity to explore the advanced features of Quality-by-Design approach and its implementations for pharmaceutical products.

The event will feature experts who are adept in this science and risk-based approaches, and therefore, will offer definitive benefits to the scientists from academia and industry working in the domains of Product Development, Process R & D, Scale-up, Manufacturing, Quality Assurance, Global Regulatory Affairs, API, Analytical method development, Excipients, Pharmaceutical Analysis, Packaging and Technology Transfer. The speakers will articulate on all the pertinent areas of QbD including Manufacturing, Formulation, Analytical Development and Excipients.

Discussion on 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, that are being followed and QbD paradigms being implemented in several pharmaceutical companies will form an integral part of this conference. 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.

Agenda 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

Another, discrete feature of this conference will be Software Training which is scheduled on the third day of the conference. For this SELECTBIO is working with the leading QbD Commercial Software Providers to provide software training on QbD related modules. Apart from this Exhibition by QbD software companies and other supporting equipments will be an attraction.