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Topic: Operation Excellence, Training & Staffing
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Therapeutic Dose: Ready, Aim, Aim, Aim…
A New Beginning for the Industry?
The Prepared Mind: Maintaining Career Optimism During Changing Times
Driving Change in an Era of Shifting Dynamics |
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White Papers: In depth research
| Title | Author | Date |
| A Perspective on Standards | Rockwell Automation | 12/17/2007 |
| This white paper by Rockwell Automation features executive viewpoints from leading standards, trade and conformity assessment organizations on why standards and regulations are important to global business, and why industry should care. | ||
| Understanding Chemometrics for Pharmaceutical Analysis | Howard Mark, Ph.D. | 05/23/2007 |
| Using chemometric algorithms, modern computer technologies and rapid spectroscopic analysis, provides the basis for the modern-day development of methods of chemical analysis with the best rewards. | ||
| Supply Risk Increasing While the Market Stands Still | Aberdeen Group | 05/21/2007 |
| From January through March 2007, Aberdeen benchmarked the supply risk measurement and management strategies of over 210 companies. Although 62% of enterprises indicate they expect supply risk to increase in the next 3 years, only 49% of organizations have implemented a supplier performance measurement and risk management program. | ||
| Do You Have a Strategy or Are You Performing Random Acts of Lean? | Aberdeen Group | 05/16/2007 |
| The key business driver to optimizing the Order to Cash cycle is the corporate mandate to improve operational performance in order to reduce costs and increase profitability. | ||
| There Is No Execution Without Integration | The Aberdeen Group, Underwritten in Part by Apriso, Rockwell Automation, Invensys Wonderware, and SAP | 05/02/2007 |
| In the many fast paced, low-margin, environments that make up the manufacturing industry it is crucial that manufacturers do not adopt technology for technology’s sake. This benchmark report by the Aberdeen Group is a roadmap for reducing overall manufacturing costs through the utilization of manufacturing technologies. | ||
| Benchmarking Report on Pharmaceutical Manufacturing | Jeffery Macher, Georgetown University, and Jackson Nickerson, Washington University | 10/12/2006 |
| This report, the result of extensive research by professors from Washington University and Georgetown University, examines cycle times, quality assurance, use of IT, employee empowerment and other factors at 42 drug manufacturing facilities to provide benchmarks. | ||
| Changes in the Business of Culture | Pedro de Noronha Pissarra | 02/27/2006 |
| This article by Biotecnol S.A.'s Pedro de Noronha Pissarra, discusses the skills sets, training, recruitment and other challenges required for successful contract biopharmaceutical manufacturing. | ||
| Process Modeling and Control Challenges in the Pharmaceutical Industry | Phil Dell'Orco, GlaxoSmithKline | 02/24/2006 |
| In this 2003 presentation made at a conference held by the University of Texas, Phil Dell'Orco, GSK's Leader for Process Safety and Design, summarized the challenges facing engineers as they work to improve control of pharmaceutical processes in an industry still dominated by chemists. | ||
| The Drug Industry at a Crossroad: PAT's Role | Efraim Shek, Ph.D., Senior Vice President, Pharmaceutical Development, NeuroMolecular Pharmaceuticals, Inc. | 12/21/2005 |
| In this 6-page PDF document, author Efraim Shek asserts that PAT is part of a new paradigm whose time has come, and suggests how PAT can become more the rule than the exception. | ||
| Improve Safety through Leadership, from Top to Bottom | Thomas Krause, Ph.D., Behavioral Science Technology, Inc. | 10/21/2005 |
| What makes a leader effective at improving and influencing safety? How can such leaders be cultivated throughout the organization? Thomas Krause, Ph.D., of Behavioral Science Technology, has the answers. | ||
| Cold Chains Are Hot: Mastering the Challenges of Temperature-Sensitive Distribution in Supply Chains | Carla Reed, Chain Link Research | 10/11/2005 |
| Unlike food products, pharmaceutical products' quality can be compromised without any visible cues. That makes proper handling of temperature-sensitive drugs all the more critical and all the more challenging. This white paper from Cold Chain Research discusses best practices and promising technologies. | ||
| Tapping the U.S. Workforce's Potential | A consortium of business and industry associations | 10/06/2005 |
| In order to realize its workforce's untapped potential, the U.S. needs to overhaul the way it teaches science and engineering, and to communicate the benefits of these fields to the young. This white paper from the Business Roundtable outlines an ambitious challenge for U.S. government and industry: double the number of students in the U.S. seeking B.S. and graduate degrees in science and engineering over the next 10 years. | ||
| Maintaining a Competitive Edge: The Role of Foreign-Born Scientists and Immigration Policies on Science and Engineering | Rob Paral and Benjamin Johnson, U.S. Immigration Policy Center | 10/06/2005 |
| In this white paper, Rob Paral and Benjamin Johnson of the U.S. Immigration Policy Center analyze the role of immigrant scientists and engineers within the U.S. economy, and consider the impact of immigration restrictions on U.S. technology development. | ||
| Assessing the Economic Contributions of Foreign Graduate Students | Keith E. Maskus, Department of Economics, University of Colorado at Boulder; and G. Chellaraj and A. Mattoo, World Bank | 10/06/2005 |
| Foreign graduate students have always played a critical role in spurring innovation and economic growth in the U.S. In this white paper, an economics professor from University of Colorado (Boulder) and colleagues from the World Bank examine their contributions in greater detail, and consider the impact that post-9/11 immigration policies may have on U.S. technology. | ||
| Integrating APC and Six Sigma for Biopharma Manufacturing | Eyal Dassau, Israel Zadok and Daniel R. Lewin, PSE Research Group, Technion IIT | 08/30/2005 |
| Daniel Lewin and his team at Israel’s Technion International Institute of Technology are studying the impact of integrating APC with Six Sigma methodologies to manufacture biopharmaceuticals. The yield improvements they’re seeing may surprise you. | ||
| Create a Six Sigma Culture | Tracy Thurkow, Ph.D., COO & Partner, CLG | 08/19/2005 |
| Many Six Sigma efforts confront cultural inertia — gravitational pull for people to do things “the way we’ve always done them.” How do you help people embrace Six Sigma? The key is to treat your efforts as a culture change. | ||
| Writing a Successful CV or Resume for Biotech | University of California, San Francisco | 08/19/2005 |
| You’re never too old to revisit the basics. This paper for students, developed by University of California-San Francisco, covers the difference between a CV and a resume, and goes over the fundamentals. | ||
| On the Cutting Edge of Lean: The Visual Workplace/Visual Thinking | Gwendolyn Galsworth, Ph.D., president, Quality Methods International | 08/10/2005 |
| Visual thinking is essential to workplace safety and efficiency, and any lean manufacturing program. | ||
| Tracking Training in FDA Environments | MasterControl Inc. | 07/06/2005 |
| Well-managed training programs minimize the risk of noncompliance and enhance product quality. Brian Curran, senior VP of product management and strategic marketing for MasterControl Inc., gives an in-depth look at how drug manufacturers can monitor and optimize employee training. | ||
| Experiment Design: The Medical Device Industry’s Lessons for Pharma | Ronald D. Fritz, president, InSite Technologies | 06/30/2005 |
| W.L. Gore’s Medical Product Division took an uncompromising approach to improving an underachieving process, and, using DOE and statistical process control techniques, turned it around. The drug industry can learn much from this story, writes Ronald D. Fritz, president of InSite Technologies. | ||
| Pharmaceutical Six Sigma Quality by Design | Ajaz S. Hussain, Ph.D., CDER, FDA | 05/26/2005 |
| Dr. Hussain's recent presentation at the 28th Annual Midwest Biopharmaceutical Statistical Workshop at Ball State University provides a detailed overview of how Six Sigma principles can best be applied to improve quality in pharmaceutical manufacturing. | ||
| Inventory Management Agreements: Challenge in the Channel | Pembroke Consulting | 05/20/2005 |
| Recent Inventory Management Agreements (IMAs) between drug manufacturers and wholesalers may have created unintended industry consequences such as increasing the risks and velocity of drug product shortages and imposing additional costs on as hospitals and pharmacies. In this white paper, Pembroke Consulting takes a critical look at the inventory impact of IMAs on companies such as Merck, Pfizer, BMS, and The Big Three drug wholesalers. | ||
| Handling MSDSs and Global Hazard Communications | Marshall Denhoff, American Industrial Hygienists Assn. | 04/29/2005 |
| Do you know all you need to know about global hazard communications and material safety data sheets? Marshall Denhoff of the American Industrial Hygienists Association shares best practices in this article. | ||
| More White Papers » | ||
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