3rd Annual International conference “QbD in Pharma Development World Congress 2015”

Страна: Индия

Город: Chandigarh

Тезисы до: 30.09.2014

Даты: 16.04.15 — 18.04.15

Е-мейл Оргкомитета: mjsingh@selectbio.com

Организаторы: SelectBio

 

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.

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, Excipients, Pharmaceutical Analysis and Technology Transfer. The speakers will articulate on all the pertinent areas of QbD Implementation including Manufacturing, Formulation, Analytical Development and Excipients.

Веб-сайт конференции: http://selectbiosciences.com/conferences/index.aspx?conf=QPDWC15