Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety LLC
Podcast: Don’t Risk Losing “Ownership” of Your Research IP as You Move to an Electronic R&D Environment
Sponsored By: Surety, LLC
As more laboratories and R&D-dependent bio-pharma and life sciences organizations move to electronic lab environments, the need to protect Scientific Intellectual Property (trade secrets, formulas, ideas and collaboration) is paramount. But if you aren’t protecting the integrity of your research data within your lab management workflows, you risk losing ownership, revenue and potentially your business if you can't prove time of creation (“first-to-invent”) and authenticity. Surety hosted a podcast series with Michael Elliot of Atrium Research & Consulting and Timothy Carroll, Partner at Loeb & Loeb, LLP, discussing important topics that can improve your organization's IP data security and integrity.
Podcast discussions include:
• Data-level security controls that must be in place to protect Scientific Intellectual Property (IP) as the” lifeblood” of the organization
• The benefits of an electronic R&D environment
• How digital timestamp technology can act as “trusted witness” to protect the integrity and legally defend the authenticity and ownership of your IP.
Listen in to this three-part series to gain valuable insights into effective and affordable IP protection for your electronic lab environment.
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Buyer’s Guide to Cold-Chain Shipping
Author: Eric Kinaitis
Sponsored By: FedEx Custom Critical
A how-to primer providing straight-forward guidance on how to evaluate a transportation provider and their capabilities in maintaining temperature-controlled cargo. |
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Improving Productivity Through Virtual Training
Author: Charles Roberson
Sponsored By: Product Animations
Virtual training has proven to be highly effective in improving productivity in the manufacturing sector. This whitepaper explores the ways that virtual training can save companies money, while increasing the knowledge-base and technical abilities of machine operators. |
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Improving Productivity with UPLC/MS Characterization and the Waters UNIFI Scientific Information System
Authors: Steve Cubbedge, Vern Tisdale, and Jeff Mazzeo
Sponsored By: Waters
With a new software platform, the UNIFI Scientific Information System, that uniquely combines chromatography and mass spectrometry techniques, Waters comprehensively unites UPLC/MS analyses and workflows. This white paper demonstrates how the Biopharmaceutical System Solution with UNIFI captures all characterization data necessary to achieve business goals for GxP biopharmaceutical laboratories. |
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How to Respond to (and Avoid) FDA 483s
Author: Ken Appel
Sponsored By: Veriteq, a Vaisala company
This article shows excerpts from recent 483s issued for deviations tracking environmental parameters in GxP applications and facilities. The article then outlines ten best practices of a 483 response, providing a checklist to make the15-day response time limit more manageable. The article includes links for further research and reading. |
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Development of an Enteric Coating Process and Stability Evaluation of PCcaps®
Authors: Balaji V. Kadri, Aran M. Johnson, Danica M. Cartwright, Ken Lo, Mark A. Cappucci & Paul F. Skultety
Sponsored By: Xcelience, LLC
Enteric coating of capsules enables innovators to overcome challenges of acidic degradation and dyspeptic side effects associated with some compounds. This whitepaper provides an evaluation of the ability of commercially available enteric, aqueous film-coating systems to confer their enteric release properties on gelatin capsules in support of pre-clinical rodent studies. |
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Processes of a Conical Rotor
Author: Shawn Engels
Sponsored By: Vector Corporation
An overview of the processes which utilize the conical rotor technology that includes spherical granulation, powder layering of actives or polymers and conventional solution/suspension application of actives or polymers. The conical rotor technology provides the ability to process micronized powders for the creation of small uniform multi-particulate dosage forms. |
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Asset Accuracy: Know What You Have and What It’s Worth
Sponsored By: EquipNet
You’ve spent millions—or even billions—of dollars equipping your state-of-the-art facilities to become a leader in your industry. And it was a smart investment! Those assets are a necessary ingredient to your company’s recipe for success, but their full value depends on your asset accuracy. Do you know what you have and what it’s worth? |
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LEV: What You Need to Know Before Selecting and Installing Dust Control Systems
Author: Max Roman, Ph.D.
Sponsored By: Kleissler PC. LLC
Meeting strict standards for low exposure levels of dust generated in the processing of materials is a challenge faced in the manufacture of Pharmaceutical products. This paper outlines critical engineering parameters for local exhaust ventilation (LEV) that are essential to meeting these standards. Special emphasis is given to the design of dust containment hoods which capture the dust at the source of emission. |
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Automated Audit Management: Mitigate Risk and Increase Productivity
Sponsored By: Sparta Systems
Today’s best-in-class enterprises are moving from manual, disparate and siloed audit management to centralized and automated audit management solutions. This whitepaper describes how audit management solutions enable life science companies to reduce audit time and cost, mitigate risk and ultimately help improve product quality and safety. |
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Getting More from your Training Budget
Author: Mr. Martin Lush
Sponsored By: NSF-DBA (USA) LLC
With training budgets getting the squeeze, more and more companies are scrutinizing the effectiveness of their training programs, asking “are we getting value for money?” As the number of warning letters and consent decrees reach unprecedented levels, regulators are also questioning the effectiveness of the training programs. Let’s assess. |
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