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Building Your Career: One-A-Day Branding

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PharmaManufacturing.com's career expert JoAnn Hines advises professionals work on your resume, write an article, start a blog, join an organization. Build your brand, one day at a time.

Overcome PAT’s Barriers and Find Its True Business Value

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A cohesive strategy and top management commitment are critical to avoid the potential pitfalls of PAT projects, says IBS Caribe CEO Manuel Hormaza.

PAT in Perspective: Headcount and PAT—Fact and Fiction

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Attention, corporate bean counters: PAT is not a magic bullet for reducing QC headcounts. In fact, it may require hiring more people, but the efforts will pay off in improved efficiencies and lower costs.

Rapid Microbiological Methods for a New Generation

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These are exciting times, says author Michael J. Miller, as 19th-century microbiological methods make way for rapid detection, quantification and characterization technologies.

The Future of Barrier Packaging

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The need for increased barrier properties and a “right first time” approach to packaging is driving new technologies and an open, scientific approach to design and implementation.

Nielsen and England: FDA’s 1980s Approach to 21st Century Import Risk

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The Agency has supply chain risk all wrong and needs to dramatically improve its IT infrastructure, say two former FDA experts.

Quiz Question Related to 21 CFR Part 11 and PAT

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Q: When measuring a process step, what is the difference between a "monitor" and an "analyzer?"

Purdue Pharma Upgrades Its Supply Chain Visibility

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By adding channel-commerce management software to its mix, a leader in pharmaceutical supply chain security strengthens its data-management capabilities.

Pharma’s Mixed-Up RFID Future

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Both HF and UHF are here to stay at the item level. ABI Research’s Sara Shah explains what it means, and provides an exclusive excerpt from her most recent report on RFID in the drug industry.

Machine Vision for Packaging Blends Science, Engineering and Art

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Vision systems are essential for maintaining product and packaging integrity and quality, but their integration requires a healthy mix of art and science.

Interphex 2006 Preview: The Best of the “Phex”

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This year's event builds upon the success of the 2005 show, with increases in both exhibitors and educational sessions.

21 CFR Part 11: It’s Not Going Away

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Will FDA’s emphasis on risk management bring new clarity to an unpopular regulation?

Mining the Hidden Factory

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Overall equipment effectiveness (OEE) can be useful in developing a pharmaceutical manufacturing excellence program, and provide a welcome bottom-line boost.

Outsourcing: Survival Strategy or Tool for Increasing Speed to Market?

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In this article, originally published in Biopharm International and reprinted on Southern Medical Associates' web site, Michelle Antonelli, Ph.D., discusses how outsourcing helped Serono improve a purification process.

Urban Legends and Misconceptions

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Columnist Emil Ciurczak urges pharmaceutical manufacturers to realize that FDA personnel and instrument vendors are on their side, and that talking with them about PAT will be more fruitful than relying on word of mouth.

S-Factors: a Tactical PAT Kit

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When is an aspirin tablet like a yacht? According to Jack Carroll, the answer to this riddle lies in five S-factors: Staff, Select, Strategize, Spend and finally, Supplant a GMP-tested product line with its parallel PAT counterpart.

IFPAC 2006 Under the Microscope

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"NIR person" and physical chemist Emil Ciurczak provides a thorough analysis of this year's IFPAC conference, held Feb. 21-23 in Arlington, Va.

Improving Energy Efficiency in Pharmaceutical Manufacturing Operations — Part...

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This two-part series will examine energy use within pharmaceutical facilities, summarize best practices and examine potential savings and return on investment. In this first article, we will focus on efficient use of motors, drives and pumps, both for process equipment and compressed air systems.

Pharmacogenomics and the Brave New World of Personalized Medicine

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FDA’s recent guidance on pharmacogenomics reduces manufacturers’ risks in evaluating genomic data. Will it spur development of more targeted therapies?

Will Pharma Wear the Energy Star?

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Some pharmaceutical plants may soon wear this badge of energy efficiency honor.

With RFID, the System is the System

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RFID’s real benefits are only found in the data and come from good systems design, as prominent case studies illustrate.

The State of the E-Pedigree Union

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Keeping up-to-date with shifting legislation is a prerequisite for e-pedigree implementation; RFID is not.

Lessons from an E-Pedigree Early Adopter

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FFF’s Patrick Schmidt discusses the cutting edge of electronic pedigrees, and shares IT challenges and the benefits of leading rather than lagging.

The New and Expanding Role of the CCO

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As pharmaceutical companies increasingly focus on regulatory concerns, a new executive role has emerged almost overnight. The latest star in the C-level pantheon at most drug makers is the chief compliance officer (CCO). What once was viewed as a part-time task, merely part of a chief legal ...

A Wave, Suspended: Follow-on Biologics

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FDA has yet to issue guidance on biosimilars, but scientific advances promise to aid regulators and enable “quality by design.”

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