- Datum: 24.09. - 25.09.2012
- Ort: Novotel Berlin am Tiergarten, Germany
- Website: http://pharma-mes.we-conect.com
MES & Process Minds 2012 will establish a new approach in finding the right MES excellence strategy for pharma and life sciences industries. International Top-Speakers at a senior executive level are, e.g.
Dr. Peter Iles-Smith
MES Technical DIrector - Global Manufacturing & Supply
GlaxoSmithKline plc / UK
Vice President Operations & Site Director
DSM Pharmaceuticals / The Netherlands
MES Director Corporate Operations
Genzyme Industrial Affairs IS / Ireland
Associate Director Automation
Genentech Inc., Hillsboro, OR / USA
Life sciences producers are faced with a multitude of new challenges. Economic pressures like globalization, litigation and government mandated pricing threaten operating margins, while an ever-changing regulatory environment makes it harder to stay compliant. New scientific bases for innovative products increase the complexity of manufacturing. Initiatives, such as targeted treatments and medicine tailored to specific subsets of patients, challenge the industry to change their supply strategy from a classic push-oriented model, to a pull-oriented model, already common in other industries.
In a regulated environment such as the pharmaceutical & Life Science Industry, it is imperative that manufacturing shop floor information is visible in the boardroom on a real time, or near real time basis to enable informed decision-making throughout the supply chain. In addition, MES projects for international markets require new processes for batch records, validation and reporting. The pharma & life sciences industry was the driving force behind many of the concepts of MES, including genealogy, electronic signatures, quality control, specifications, batch execution, paperless batch etc. Of particular importance for this industry is to ensure process quality, efficiency and safety.
Process understanding will be the key to manage these challenges and to build an efficient pharmaceutical production. Manufacturers will have to turn to fully integrated IT solutions to achieve operational excellence.
In this regard Manufacturing IT such as Manufacturing Execution Systems is one of the key business enablers for reaching Operational Excellence. An MES controls, optimizes, and documents business processes executed on the shop floor in full compliance with all the pharmaceutical requirements. It is the goal of an MES to increase security and reliability of the manufacturing process and to improve product quality.
Cost effectiveness is another important element, mainly for gaining approval for MES projects. In order to develop an ROI program for an MES, project leaders and stakeholders must be able to identify the long-term goals of their manufacturing execution process and often justify projects with hard cost savings. Here, the question is where the major cost drivers for MES projects are and which strategy is the right one to reduce costs.
On the other hand MES has a high potential for new plant construction, particularly when the production has a high degree of automation and material flow. MES reduces the expenses for the documentation of production data, Batch losses due to event management and functions of the MES systems are dramatically reduced. The functions of MES go far beyond the horizontal and vertical integration, MES is positioned as an independent system of its functions, in various models such as the NAMUR S-88, ISA, FDA or the MESA-c-MES model, MES has already been integrated. The Web technology opens the way for Web-based Systems to be networked in production. The companies are global "on-time-and on-location" which means they can get real-time date at their mobile terminals.
In addition, an efficient and integrated MES provides full visibility, real-time monitoring of production lines according to the different roles, tasks and permissions in production management of the pharma & life sciences industry. It is now time to expand the level of integration and automation further to a more flexible manner to respond to changing market demands.
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