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The Complete Word on Supply Chain Risk

(Whitepaper)

The Product Surety Center's 2005 Symposium on Risk in Supply Chains was the place to be for progressive thought on supply chain issues. Here are summaries of all key presentations.

Logistics, the Next Generation

(Whitepaper)

Logistical and manufacturing systems must merge and evolve with tracking technologies if the supply chain is to be truly secure. Magnar Løken d.y., CEO of Norwegian software firm Kezzler AS, shows how it’s done.

Using a Real Options Approach to Achieve Manufacturing Flexibility

(Whitepaper)

Good pharmaceutical investment decisions often translate into tremendous profits and market opportunities. Sanofi-Pasteur’s Dr. Guillaume Pfefer and Uriel Kusiatin, principal and co-founder of 2Value Consulting Group, outline new methods for decision-makers to get the most bang for their bucks.

Don't Say 'Used': How to Select Pre-Owned Equipment

(Whitepaper)

Buying pre-owned equipment can be risky, but it can also save money and increase production if you know what to look for. Frain Industries' K.C. Christensen offers tips for smart shopping.

Server Consolidation in a Validated Environment

(Whitepaper)

A sure way to achieve IT cost savings is to consolidate validated applications onto virtual servers. Just be sure you have a top-notch change management process, says Keith Parent, CEO of Court Square Data Group.

How MES Enables PAT

(Whitepaper)

A Manufacturing Execution System provides a framework for PAT, allowing for enhanced productivity and quality, says Joseph Vinhais, vice president of regulatory compliance at Camstar Systems.

On the Cutting Edge of Lean: The Visual Workplace/Visual Thinking

(Whitepaper)

The Visual Workplace shows how a visual approach to the manufacturing workplace can reduce errors and improve safety and productivity.

Writing a Successful CV or Resume for Biotech

(Whitepaper)

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.

Total Bar Code Quality

(Whitepaper)

The quality of each bar code is not always black and white, and manufacturers need means of verification to determine the effectiveness of each code and label. This succinct but substantive paper by platemaker Quint Co. sheds light on verification methods and bar code standards.

Create a Six Sigma Culture

(Whitepaper)

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, says Tracy Thurkow, Ph.D., COO & Partner, CLG.

CDER's 2004 Report to the Nation: Improving Public Health Through Human Drugs

(Whitepaper)

This 66-page report discusses what was accomplished by FDA's Center for Drug Evaluation and Research in 2004, and looks at the initiatives it will be tackling this year and in the near future.

ERP and Lessons to Be Learned

(Whitepaper)

In the late 1990s, the drug distribution firm FoxMeyer sued its ERP vendor and implementation specialist, Arthur Andersen, claiming that its ERP installation had driven it into bankruptcy. In this discussion at the University of Singapore, experts dissect the case and lessons that drug companies ...

21 CFR 11: Risks of Noncompliance

(Whitepaper)

This paper addresses major concerns about interpretation of the regulation and the ensuing release of "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application" in August 2003. It also explains FDA's clarification of two points: (1) FDA intends to ...

Roadmap to Operational Excellence

(Whitepaper)

In this special guide for pharmaceutical manufacturing professionals, Emerson Process Management outlines the best practices you can use to establish a culture of continuous improvement and achieve operational excellence within your organization.

Use of Atomic Force Microscopy to Accelerate Drug Development

(Whitepaper)

This applications note by J.Y. Zhu of Molecular Imaging Corp., discusses AFM and its potential in accelerating drug development.

NIR-based PAT Replaces HPLC for Bottling

(Whitepaper)

This application note from Uhlmann VisioTec discusses NIR spectroscopy, offering some insights into how it was used to replace HPLC analysis at a pilot-scale pharmaceutical suspension bottling line.

Using RFID and PKI to Secure the Pharma Supply Chain

(Whitepaper)

It’s a marriage of two of the hottest security technologies — radio frequency ID and public key infrastructure. Texas Instruments offers tips for a happy union.

Integrating APC and Six Sigma for Biopharma Manufacturing

(Whitepaper)

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.

Meeting the Counterfeit Drug Challenge

(Whitepaper)

Think-tank fellow and former FDA associate commissioner Peter Pitts discusses what can be done about the growing global public health threat posed by drug counterfeiters.

What’s Your Security Confidence Rating?

(Whitepaper)

Securing the pharmaceutical supply chain requires a multilateral approach, with high confidence in all aspects. An authenticated RFID system is a critical component, explains Andrew Dubner, 3M senior specialist and Six Sigma Black Belt.

Secrets to Finding a Job in a Tough Market

(Whitepaper)

Ignore those who say to keep your resume short. Don’t state your individual goals. Job search specialists Challenger, Gray & Christmas have found that following “the conventional wisdom” may not yield the best results.

PAT and Pharma Competence

(Whitepaper)

This Guide to Process Analytical Technology analyzes the industry’s needs and discusses Siemens' multidisciplinary approach to meeting them.

How the Other Side Lives: FDA’s Experience with Enterprise IT

(Whitepaper)

Has your company moved to new enterprise architecture software? Well, so has FDA. Read this quick report and compare your strategy, challenges and experiences with those of the Agency.

MVA Modeling without Tears

(Whitepaper)

Curvaceous Software’s C:Suite Process Modeler uses geometric process control to handle quality control, process control and alarm management. Founder Robin Brooks and his colleagues discuss how it works, in an article originally published by IEEE.

Assessing the Economic Contributions of Foreign Graduate Students

(Whitepaper)

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 ...

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