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Featured Whitepaper
Charged Aerosol Detection in Pharmaceutical Analysis
Authors: By Michael Swartz, Ph.D., Mark Emanuele, Amber Awad, Adam Grenier, and Deborah HartleSponsored By: Synomics Pharma
Corona charged aerosol detection (CAD®) has become a widely used technology in the pharmaceutical laboratory, due to advantages of sensitivity, dynamic range, and applicability to a wide range of analyses in the drug development process. This white paper examines the operation and use of CAD in a regulated environment, addressing method development and validation specifics.
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ERP strategies and Best Practices for Emerging Life Science Companies
Sponsored by: CDC Ross Enterprise
Savvy business and financial managers in today’s emerging Life Science companies increasingly recognize the need to establish an effective business infrastructure early in the lifecycle of the company. These managers recognize the inherent advantages to establishing scalable business processes and information systems early in the companies’ growth. In support of its present and future customers, CDC Software sponsored this white paper to help emerging Life Science companies understand the ERP strategies and best practices being pursued by leading companies in the industry. Through the experiences of two of the customers highlighted in this paper, emerging Life Science companies can learn from and apply some of the best practices and lessons learned from peer companies. |
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Protect Your Intellectual Property: Proof of Authenticity is Your Best Defense
Sponsored by: Surety, LLC
As a pharmaceutical or biotechnology organization, your formulas, treatments and discoveries are the “lifeblood” of your business. But if you aren't protecting the integrity of your scientific content, you risk losing ownership, revenue and consequently your business if you can't prove time-of-creation and authenticity. Learn how you can implement simple, cost-effective, and transparent controls to protect your intellectual property data. |
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Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT
Author: Justin Neway, Vice President and Chief Science Officer Sponsored By: Aegis Analytical Corp.
Quality by Design (QbD) starts in process development. This is where the best opportunity exists to design improved processes based on new process measurements and by taking advantage of previous experiences with similar processes. With the introduction of Process Analytical Technology (PAT) as a tool for achieving QbD in pharmaceutical and biotechnology processes, the volume of electronic and paper-based data collected during process development and manufacturing has increased dramatically. A critical success factor for achieving the goals of QbD is thus to provide on-demand access all of this data for end users in a collaborative analytics, trending and reporting environment in which the multidisciplinary team can collaborate productively. |
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The Science Behind Smart Outsourcing
Author: Tina Sturgill, Site Director
Sponsored By: Celsis Analytical Services
Knowing when and if outsourcing laboratory services makes sense is critical. This white paper focuses on the steps companies should follow for deciding if outsourcing is the best option, how to evaluate funding an in-house laboratory, and how to use the Celsis Workload Assessment Model to manage labor cost decisions. |
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Topical Dermatological Formulation Development - "Things You Should Know"
Author: Vanlee Waters M.B.A., Marketing Manager
Sponsored By: Dow Pharmaceutical Sciences, Inc.
"Things You Should Know" will answer many of your questions and will provide insight into issues you may not have considered -- but should be aware when developing a topical formulation. The target product profile, dosage form selection, reasons for multiple excipients, the formulation development process, prototype screening, and lead formulation selection are discussed. |
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Inspection of Tablets: Assuring Product Quality at Manufacturing and Packaging
Sponsored By: Symetix
Achieve new levels of product quality and inspection efficiency in the manufacturing and packaging of tablets. Learn the pros and cons of manual inspection, mechanical sorting, blistering, single-file optical systems and a new class of automated, bulk vision inspection systems. The latest technology is keeping pace with the increasing demand for top-quality products. Learn how it helps minimize risk, increase throughput and contain costs. |
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Using Photostability Chambers to Meet Requirements of ICH, Q1B
Author: Bob Dotterer
Sponsored By: Caron Products & Services, Inc.
For companies performing photostability testing in accordance with ICH Guidelines, Q1B, Caron’s 6540 series chambers overcome the challenges of lamp selection, light control and other chamber design issues. By integrating technical requirements with practical solutions, Caron’s Photostability Chambers enhance the testing process to ensure product quality and regulatory compliance. |
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An Overview of Pharmaceutical Filling Systems
Author: Matthias Poslovski; Sponsored By: Optima
Several factors must be considered for the competent selection of a filling system for sterile pharmaceutical liquids. Important aspects to be taken into account are the various product properties of the filling materials, ambient conditions of the filling process, required format range and output, and filling precision. All pharmaceutical filling systems hold benefits and drawbacks. Consequently, each different application requires thorough analysis. |
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TECHNICAL TRANSFER DOCUMENTATION IS KEY FOR SUCCESS
Author: Tom Hughes
Sponsored by: Carton Service-Packaging Insights
Clearly defined objectives and project requirements between the pharmaceutical company and their contract packager need to be spelled out – in writing – in a Technical Transfer Document prior to any pharma packaging project. A published report documenting details for the customer and the packager is a critical component for success. |
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