FINDING THE COMMON ROAD TO QUALITY FOR SINGLE-USE MATERIALS

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Presented by

Dr Trishna Ray-Chaudhuri, Genentech & Dr Hélène Pora of Pall Biotech |

About this talk

– GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing. The drug product produced in clinical studies are given to patients. – GMP practices followed in producing the single use assemblies will ensure that there is no risk to patients in clinical trials and future commercial products. IF WE CAN”T PROVE GMP WHAT HAPPENS? -Single use assemblies will not be accepted by regulatory agencies and internal quality departments as an alternative to stainless steel tanks. -The perception will continue that there is inadequate quality controls on single use assemblies as GMP practices are not adequately followed. – Implementation of single will be inhibited Presented by Dr Trishna Ray-Chaudhuri, Senior QC Scientist in Direct Materials in Global Analytical Sciences & Technology / Global QC, Genentech DRiIVING QUALITY & RESPONSIVENESS IN SINGLE-USE TECHNOLOGIES Single-use technologies require a shift of responsibility from biomanufacturers to suppliers to enable production of safe and reliable drugs. One of the pre-requisites for efficient supply is to have standardized processes to design and manufacture single-use systems. Pall has developed a unique design, quality and business tool to drive quality and responsiveness, and to support standardization of single-use technologies. We will take you through the functionalities of this system and demonstrate what benefits it brings to end users when implementing single-use technologies in a regulated environment. Presented by Dr Hélène Pora, Vice President Technical Communication & Regulatory Strategy , Pall Biotech

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