cGMPs

Implementation of Quality by Design Set to Steer Asian Pharma

Oct 16, 2013

PR Newswire

CPhI Conferences announces a three-day technical conference, Quality by Design, taking place from November 25-27 in Kuala Lumpur, Malaysia. The event also includes an exclusive two-day workshop, "Quality by Design Implementation Roadmap Masterclass"  by Mr. Emil W. Ciurczak who was a member of the PAT sub-committee (Validation) for the FDA and is a member of the PAT Expert Committee for the USP.

With Asia emerging as a powerhouse of pharmaceutical Research & Development (R&D) facilitated by the availability of a vast patient population, quality data, lower costs and skilled manpower, the implementation of Quality by Design will steer the industry towards better safety and quality whilst reducing cost and time. Mr. Ciurczak notes, "I believe, based on my observance, that there are more opportunities in Asia than even Europe or the US. This is mainly because the generics industry is growing very rapidly in Asia and FDA/EMA oversight is becoming stronger. Thus, the two main motivators for Asian companies are compliance and profit. I say profit because whichever generics company adapts PAT/QbD techniques will have an advantage over competitors."

The conference agenda is specifically designed for those in the research and development, formulation, analytical, quality control, quality assurance and regulatory working in pharmaceuticals, as well as organisations and institutions that devote the majority of their efforts to research, development, technology transfer, or commercialisation of pharmaceuticals.

The program will focus on the drivers, regulatory framework, risks, principles and approach for QbD, and the benefits for the pharmaceutical industry in Asia to implement QbD to compete in the global arena. This event is a unique learning platform combining discussions, case studies and best practice to enhance knowledge sharing and networking; coupled with a practical training component to enhance applied and technical implementation know-how.

For more information about CPhI - Quality by Design, please visit: www.qualitybydesign-asia.com