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Sponsor
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What Machine Vision Can Do For You
Manufacturers and packagers know that a defective product or imperfect package carries a negative message about their brand into the marketplace. A white paper by METTLER-TOLEDO CI-Vision describes how modern vision systems can help protect your brand and profitability. Download here.
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From The Publisher
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Welcome back to the Pharmaceutical Online newsletter and our special report on the 2010 PDA Annual Meeting, taking place March 15 to 19 at the Gaylord Palms Resort and Convention Center in Kissimmee, FL.
The PDA Annual Meeting is the one meeting each year dedicated to advancing the careers of pharmaceutical and biopharmaceutical professionals by focusing program content on science and technology innovation, offering extensive formal and informal networking opportunities and providing a forum to contribute to, and influence the advancement of science and regulation in the industry. If you plan to attend, be sure to visit the suppliers listed below in our special report. If you would like more information, please visit the links below.
Register for the PDA Annual Meeting.
View the courses offered this year.
John Clifton, Vice President of Publishing, VertMarkets, Inc.
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Featured Articles
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Noncompliance To FDA Quality Standards: What's The Risk To Executives?
By Michael S. Heyl, Attorney at Law, MasterControl
Just imagine. Your life science company — hypothetically speaking — is now a successful and growth-oriented
organization. Thus far, you've kept governmental regulations in check, quality is steadily
improving, and you've even managed to lower the cost of production. Then one day when operations
seem calm, smooth — even simple — the U.S. Food and Drug Administration (FDA) shows up for an
unannounced inspection of your facility. Your confidence is still high. Everything seems to be in order.
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The Industry Outlook For 2010
By Billy Tauzin, President and CEO, Pharmaceutical Research and Manufacturers of America (PhRMA)
What is the 2010 outlook for America's pharmaceutical research and biotechnology companies? Well, there's no easy answer. What we can say is that 2010 looks to be a critical year that could help determine the future course for the industry for years to come. America's biopharmaceutical research companies have a long history of developing medicines to help patients live longer, healthier, more productive lives.
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Development And Quantification Of H2O2 Decontamination Cycles
By PharmaSystems, Inc.
Whereas correlation of physical process parameters with bacterial reduction is well established
in thermal sterilisation, such a method is currently neither generally recognised nor possible for H2O2
decontamination. As a result, the efficiency and reproducibility of H2O2 decontamination and the course of the
process over time can at present only be ascertained, verified, and documented using a microbiological system.
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Better Wet Granulation: Development, Scale-Up And Manufacture
By Tim Freeman, Freeman Technology
Wet granulation is a common unit operation in the pharmaceutical industry, yet accurate endpoint detection remains a challenge. Here, we examine the contribution that dynamic powder rheometry can make, highlighting its ability to detect the transition from wet mass to granulate with the required sensitivity. Quantification of this transition point, with a measure that is independent of process scale, accelerates development and scale-up and improves manufacture.
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Codelco Selects Thermo Scientific SampleManager LIMS™ To Improve Productivity And Efficiency
By Thermo Scientific Brand Products, Part of Thermo Fisher
The Corporacion Nacional del Cobre de Chile (Codelco) is the main copper producer in the world, controlling approximately 20 percent of the world's copper reserves.
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Special Report: PDA Annual Meeting
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Product Sheet: VeriPac 325/D — Nondestructive Leak Testing For Filled And Sealed Pouches
VeriPac 325/D is a versatile package inspection system for foil barrier pouches and poly peelable chevron designed pouches. The test configuration features a convenient, drawer-style chamber for easy handling and testing convenience. The VeriPac 325/D is capable of testing different size pouches and even multiple pouches without any changeover in parts or system settings.
PDA Booth 533
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Brochure: Bosch Capsule Filling — GKF 700
The GKF 700 uses a precision functional process in which the capsules are aligned, opened, filled, and reclosed. Capsules inserted cap first, nonseparated capsules, and capsules with two caps are recognized and rejected.
PDA Booth 722
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Datasheet: VHP M1000-T4 Biodecontamination System
For low temperature sterilization of isolators, workstations, aseptic filling lines, rooms, etc. in research, biological safety, and production applications.
PDA Booth 426
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Brochure: Production Filling And Transfer Isolators
SKAN AG, the developer of the integrated hydrogen peroxide (H2O2) decontamination system, is the world's leading provider of pharmaceutical isolators for product and personal protection.
PDA Booth 508
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Brochure: Bonfiglioli BLI Series Pharmaceutical Blister Leak Testing Machine
Features include precision control, high repeatability,
very low noise levels, and easy cleaning.
PDA Booth 609
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Brochure: MFCS® Training
Our training courses are specifically designed to
enable end users to fully exploit the wide range of
options included in the MFCS/win SCADA software
packages. Training can be performed at
Sartorius Stedim Biotech in Bethlehem, PA, or at the
customer site.
PDA Booth 601
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Product Brochure: Global Regulatory Services
Catalent's regulatory and clinical experts have a wide range of in-depth experience with both established and novel pharmaceutical dosage forms across a wide range of therapeutic areas. The global regulatory services group has an extensive consulting portfolio.
PDA Booth 525
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Brochure: LAL Reagents
Limulus Amebocyte Lysate (LAL) tests detect and quantify
bacterial endotoxins extracted from the outer wall of gram
negative bacteria.
PDA Booth 624
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Fact Sheet: HollisterStier Contract Manufacturing
Contract Manufacturing at HollisterStier is located in a 190,000 sq. ft. facility situated on 20 acres in Spokane, WA. With over 500 employees, HollisterStier has become recognized globally for our quality and project execution, strong regulatory track record, and our ability to provide "one stop shop" services to customers.
PDA Booth 323
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Featured Multimedia
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| Presentation: Introduction To Biosafety Cabinets |
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Microbiologists are very concerned about maintaining a contamination-free work
area. Therefore, you will notice that a biosafety cabinet is generally cleaned daily
and kept free of excessive equipment.
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Training
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Featured Courses From The Center For Professional Innovation And Education
Project Management For The Phase 3 And LCM (Life Cycle Management) Of The Drug Development Process
April 12 and 13 | Dublin, Ireland
How To Monitor Clinical Trials For GCP Compliance
April 12 and 13 | King of Prussia, PA
Best Practices For Facilities And Utilities Design, Qualification, And Monitoring: Applying The Life-Cycle Concept
April 12 and 13 | King of Prussia, PA
Effective Qualification And Monitoring Of Processing Equipment And Their Control Systems
April 14 and 15 | King of Prussia, PA
Detecting Fraud And Misconduct In Clinical Trials
April 14 and 15 | King of Prussia, PA
Pediatric Clinical Trial Design: Ethics, Management, And Regulatory Requirements
April 20 and 21 | King of Prussia, PA
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Submission Information
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Pharmaceutical Online invites members of the community to submit their technical articles,
application notes, white papers, tutorials, videos, press releases, and other relevant content for featuring on www.pharmaceuticalonline.com and in our e-mail newsletter.
Please send your submissions or questions to us at editor@pharmaceuticalonline.com.
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