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View Sub-Track: Sessions on Operational Excellance

Friday, March 05, 2010

Risk based approach to incorporate your Critical Utilities in a Measurements and Verification Program
Room: 202B ~ 9:00AM - 10:30AM (Friday, March 05, 2010)

Sponsored by ISPE:

Losses associated with poor operation and maintenance cost industry every year. However, the decision to make needed improvements is sometimes based not only on the ability to quantify the value of savings but on the potential impact on the "Validated State" of a system.

Improved Operations and Maintenance Programs offer an opportunity to lower costs and increase profits by using existing systems and equipment more effectively.

Risk based approaches can enable the use of such existing systems and equipment by lowering implementation costs and avoiding excessive and sometimes unnecessary validation costs.

Speaker:

Cesar Echevarria - Director of Opertaions , Commissioning Agents

How to Plan and Excute a Successful Plant Start-up, the Medical Device Way
Room: 203 ~ 9:00AM - 10:30AM (Friday, March 05, 2010)

During the session we will be sharing best practices to plan and execute a plant start up once a decision of project execution has being already made. Several key success factors will be explored: Project Management, Plant Design, Equipment Installation and Validation, Human Resources, Quality Systems Implementation and Manufacturing Readiness. These key factors will be analyzed within a Project Management, Lean Manufacturing and Maintenance Excellence framework defining the foundation for a successful operation start up. The Lifescan Products LLC facility located in Aguadilla will be the Business Case used to analyze best practices and lessons learned and leverage the experience and knowledge with the Medical Devices Industry.

Speaker:

Aileen Barreto - Operations Directoy, LifeScan Products LLC

Case Study in a Active Pharmaceutical Ingredient Facility (API)- Use of Contract Labor to Improve Reliability Maintenance and Reduce Operating Costs
Room: 202C ~ 1:15PM - 2:45PM (Friday, March 05, 2010)

Sponsored by ISPE:

The audience will learn the value proposition in using contract labor to perform proprietary maintenance and support manufacturing operations under cGMP conditions. This case study will illustrate how a flexible work force concept can result in improved productivity and reduce the labor portion of the fixed cost. Presenters will provide their experience and views from the executive suite to the operating floor. For businesses that are experiencing pressure from the corporate headquarters to reduce costs while maintaining vacillating production schedules, this presentation outlines the strategy employed by Fortune 100 companies – to focus on core competencies and outsource non-core task and disciplines. Learn how to analyze the workforce to determine the “low hanging fruit ‘. Participants will take away the critical items to consider when evaluating maintenance contractors. Understand what NOT to do when designing your contracting strategy. The strategies and programs presented on this case study are applicable in a Pharmaceutical, Biotech and Medical Device manufacturing environment.

Speaker:

Edward W. Foster - CMPR VP, The Mundy Companies

Mike Mills - Business Development Manager, The Mundy Companies

Colin Orgill - Site Manager, BASF

Joe Rettinger - Founder CEO Soliance, Soliance

John M. Rocco - Executive VP, Mundy PharmaTech

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.

Speaker:

Dorcas Y. Lopez - Strategy & OE Associate Director, Pfizer

Jennise Neris - Technology Manager, Pfizer

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