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View Sub-Track: Sessions on Productivity |
| Thursday, March 04, 2010 |
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MES Implementation
Room: 202A ~ 9:00AM - 10:30AM (Thursday, March 04, 2010)
| The MES implementation improved the efficiency in the batch record documentation and process reliability. Some of the benefits are the control of the raw material information that was sent automatically by SAP and controlled by MES, the reduction in documentation investigations, thus reducing the cycle time in the batch record release. The improvement in the process flow in the areas identified eliminates unnecessary delays by paper batch record management, with no paper records lost in the process and no paper maintenance. Additionally, the employee productivity was improved by reducing the documentation effort. The project provided over 500K hard/soft savings after implementation.
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Calculating ROI for Automation Projects - Unmasking the True Value
Room: 202A ~ 10:45AM - 12:15PM (Thursday, March 04, 2010)
| The economic environment around the globe has put a new focus on finding ways to improve manufacturing operations, reduce costs, and increase throughput. Automation projects are often proposed and evaluated to help meet these goals. But what does an Automation project truly cost? And what value does it bring? How reliable are preliminary estimates as compared to the final project costs? In this session, the participant will learn how to calculate the true Return on Investment for Automation projects. This understanding can help direct energies to the projects which have the greatest potential for approval and success. This session will remove the mystique of Automation project development, costs, and benefits, with a strong emphasis on added value, ROI, and life-cycle costs. Managers and executives will learn how to objectively evaluate Automation projects against business drivers, while engineers and technicians will gain a better understanding of how to approach Automation projects to maximize financial returns. Examples from the presenter's own experience as well as that of others in the industry will be used to quantitatively analyze several case studies. By using these analytical methods, participants will be able to evaluate their own projects and be more confident that their management will fund their projects based on sound economic calculations.
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Managing the Product Lifecycle in a Global Environment
Room: 202C ~ 1:45PM - 3:15PM (Thursday, March 04, 2010)
| Are medical device companies moving beyond “throwing it over the wall” waterfall processes to a more cohesive Total Product Lifecycle approach as the FDA proposes?
To determine the industry’s adoption of the Total Product Life Cycle (TPLC) approach advocated CDRH, Axendia in cooperation with Cambashi and FDANews recently conducted a major research project on this subject.
A total of 212 industry insiders from a wide range of medical device and diagnostic companies participated in this research.
This session will cover key findings analysis and recommendations from this research study.
Attendees will discover:
• The current state of product lifecycle management medical device industry
• How industry leaders are meeting today’s global challenges
• What benefits companies can gain by taking Product Lifecycle approach
• Strategies, best practices and information systems to enable this transformation
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| Friday, March 05, 2010 |
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All Downtime is Not Equal: Measuring Performance with Overall Equipment Effectiveness
Room: 202C ~ 10:45AM - 12:15PM (Friday, March 05, 2010)
| Manufacturers today have started using an important metric for measuring and monitoring performance in factories. The metric is known as overall equipment effectiveness, OEE. This metric combines process availability, machine performance and the output impact of quality in the form of rejected product. This metric provides a universal yardstick to measure operations performance. Businesses can realize tremendous gains when they focus on the largest inhibitors of performance.
In a typical initiative to improve overall equipment effectiveness, the starting point is to establish ideal production rates. Ideal capacity, based on planned production, represents 100%. Overall equipment effectiveness (OEE) is the measurement of the final result. It is the cumulative result of the elements that can detract from “perfect production”: availability, performance and quality.
Speaker:John Oskin - Executive Vice President, Informance International |
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Bridging the Gap Between Market Demands and Tablet Coating: The Role of Flexible Manufacturing
Room: 202B ~ 1:15PM - 2:45PM (Friday, March 05, 2010)
| Recent trends in the pharmaceuticals market are forcing manufacturers to respond faster than ever to changing market influences such as erosion of branded drugs by generics, market segmentation for smaller patient subpopulations, variable product mix and batch sizes, and the increasing role of contract manufacturers. Solid dosage producers are looking toward flexible manufacturing strategies to help them remain competitive and profitable as conventional business models are being replaced by newer ones that reflect today’s market.
For many years, flexible manufacturing strategies have been in place for tablet compression and packaging operations. While parallel strategies aren’t being fully utilized yet for production scale coating, several useful concepts are already being widely used on R&D and pilot scale tablet coating projects.
This seminar will discuss how proven coating technologies on R&D and pilot scales can be adapted for use at the production scale to achieve manufacturing flexibility and enhanced utilization.
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Transformation: A Case Study of how the Pfizer Carolina Site is Reinventing Itself and Focusing on Action
Room: 202A ~ 1:15PM - 2:45PM (Friday, March 05, 2010)
| The pharmaceutical industry is facing unprecedented challenges and is changing rapidly. We are expected to be more efficient, cost-effective and agile in our decision-making. Global regulatory agencies are expecting that the industry exceeds requirements for regulatory compliance. In that context, learn the story of how Carolina identified tangible and measurable opportunities to improve operational efficiency, compliance and business flexibility to come up to these challenges in the pharmaceutical industry.
This actual case study will present the strategic approach followed to transform and renew the organization using LSS principles and mindset & capabilities building. Taking theoretical concepts to a next level with the “Carolina PRo” challenge. Activities that can become best practices examples not only at one company but to the whole pharmaceutical industry. In addition, what elements are needed for a successful deployment and the lessons learned during the continuous journey for improvement. The case study also demonstrates the benefits of people engagement for sustainable results.
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