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Quality by Design - The Pathway to Manufacturing Excellence for Asia's Pharmaceutical Industry

2013-10-30 18:17 1582

KUALA LUMPUR, Malaysia, Oct. 30, 2013 /PRNewswire/ -- The pharmaceutical industry landscape is shifting, particularly in the context of the recent unstable economic climate with the relocation of the focus of research and production from Europe and US to Asia. With this shift, the implementation of Quality by Design (QbD) in manufacturing of medicines, Asian manufacturers will achieve safety and quality whilst reducing cost and time. Mr. Emil W. Ciurczak, workshop leader during the event notes, "When developing a new product or dosage form, the proper manufacturing conditions as well as excipient / API ratios can be developed far, far faster with fewer trials than traditional "hunt and peck" development when QbD is implemented in the product development of medicines."

CPhI Conferences announces a three-day technical conference, Quality by Design, taking place from 25 - 27 November 2013 in Kuala Lumpur, Malaysia. The event also includes an exclusive two-day workshop, "Quality by Design Implementation Roadmap Masterclass" on 26 - 27 November 2013 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.

CPhI - Quality by Design 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. Mr. Nitin Madhukar Kadam, Assistant Manager, R&D (Formulation), Medica Pharmaceuticals Industries, commented, "QbD is a systemic approach to product development whereby manufacturers should have a ready blueprint of their products before commencing work on the actual development which reflects the complete understanding of product and process with in-depth knowledge, science, experience and technical soundness. QbD can change the efficiency of manufacturing from low to high and provide most the reliable, reproducible and robust manufacturing process. QbD can minimise waste as QbD evokes trial and error approach. QbD provides the opportunity of technology innovation with less technical and financial risk."

The must-attend event will help attendees get an overview of overall opportunities and challenges in implementing QbD and a in-depth workshop to guide attendees on implementing QbD. The 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.

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

Source: UBM Conferences (ASEAN)
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