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The Coming Wireless Market

(Whitepaper)

The North American market for wireless monitoring and control products is taking off. This paper by Venture Development Corp. tells which direction it’s headed.

Long-term Benefits of Adopting RFID Technology

(Whitepaper)

Wal-Mart's mandate that its top suppliers must put RFID tags on cases and pallets of consumer goods by January 2005 has pushed manufacturers toward the technology, despite reservations about ROI. Rockwell Automation's "RFID in Manufacturing" White Paper provides a practical guide to extracting ...

The Business Case for PAT

(Whitepaper)

Having trouble justifying PAT projects to top management? The business drivers for PAT are compelling, both on the regulatory and on the financial side. This Rockwell Automation white paper discusses how to conduct a "productivity improvement appraisal" and how to handle discovery and analysis ...

Jump-Starting RFID in the Pharmaceutical Supply Chain

(Whitepaper)

A group of pharma manufacturers, wholesalers, retailers and associations cooperated on a landmark project to determine the costs and benefits of adopting RFID and EPC across the value chain. Accenture's executive summary discusses what was learned in Phase 1 of the project.

Realizing Pharmaceutical Quality by Design

(Whitepaper)

Quality cannot be tested into products. It has to be built in or by design. Pharmaceutical quality systems should be based on this premise, says Ajaz Hussein, deputy director of FDA's Office of Pharmaceutical Science, but there are "significant gaps" in its application. This presentation focuses ...

Implementing a Global 21 CFR Part 11-Compliant CAPA System

(Whitepaper)

This case study shows how Bausch & Lomb benefitted from implementing AssurX's CATSWeb software.

Advances in Large-Scale Biopharmaceutical Manufacturing: Contents and Foreword

(Whitepaper)

Volume One of "Advances in Large-Scale Biopharmaceutical Manufacturing and Scale-Up Production" (published in October 2004 by ASM Press) features insight and analysis of emerging technologies and scientific advancements by dozens of the leading authorities in the field.

FDA Goes "Final" with Its 21st Century cGMP Guidance

(Whitepaper)

FDA's final report on “Pharmaceutical cGMPs for the 21st Century — a Risk-Based Approach” is hot off the press. From aseptic processing to electronic record-keeping to quality systems, get your guidance here.

PAT Answers: FDA's Final Guidance

(Whitepaper)

FDA recently released its final guidance on process analytical technology, “PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," as part of its broader 21st Century cGMP initiative.

Flu Vaccine Testimony: Chiron's View on Preparedness

(Whitepaper)

In early 2004, long before the news that Chiron Corp.'s Fluvirin would not be available for the 2004-2005 flu season, firm president Howard Pien testified before the U.S. House of Representatives about the company's role in meeting the nation's vaccine needs. Read what he had to say.

Making Sense of FDA's Risk-Based Initiative

(Whitepaper)

Here's a no-nonsense three-page overview of FDA's 21st Century cGMP guidelines, written by attorney Patricia J. Kaeding, formerly of FDA's Office of Chief Counsel.

Getting a Grip on Paperless Reporting

(Whitepaper)

Flu Vaccine Testimony: MedImmune's View

(Whitepaper)

Now that Chiron Corp.'s Fluvirin will not be available for the 2004-2005 flu season, MedImmune, Inc., maker of FluMist, takes on a major role in the nation's flu preparedness. In early 2004, Dr. Jim Young, the firm's president of R&D, testified before the U.S. House of Representatives about what ...

Trade Shows are Good for You

(Whitepaper)

Biopharma's Impact from State to State

(Whitepaper)

The biopharmaceutical industry has had a tremendous impact upon nationwide employment. Some states benefit more than others, however. This study shows which states gain the most from biopharma.

Want Cheaper RFID? Go Offshore

(Whitepaper)

RFID Labeling Guidance from AIM

(Whitepaper)

21CFR Part 11 Remediation Strategies

(Whitepaper)

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