Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety
Case Study: Leading Pharma Co. Protects IP and Streamlines “Sign & Witness” Process using Integrated, Trusted Timestamping
Sponsored By: Surety, LLC
For this large pharmaceutical company, the legal protection of their intellectual property research data in their lab management workflows was questionable – they could lose ownership, revenue and potentially their business if they couldn’t prove time of creation (“first-to-invent”) and authenticity decades into the future. Learn how they integrated a simple, automated control to protect their scientific intellectual property, and streamlined their “signing and witnessing” processes for legal defensibility. Without such a control, the company could expose itself to lost IP claims, rejected patents, and ultimately lost revenue. |
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Risk Evaluation and Mitigations Strategies and the FDAAA
Authors: Debra Norman, Ph.D., JD & Gary Hindman, Ph.D.
Sponsored By: Beckloff Associates, Inc.
On March 25, 2008, new legislation designated as the Food and Drug Administration
Amendments Act of 2007 (FDAAA; “the Act”) took effect, which directed FDA to develop a
systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout
its lifecycle, with an explicit focus on postapproval safety. In September 2009, FDA announced a draft guidance to assist sponsors in the preparation of a REMS. The guidance provides links to a number of resources available at FDA to aid in REMS preparation. |
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Charged Aerosol Detection in Pharmaceutical Analysis
Authors:
Michael Swartz, Ph.D., Mark Emanuele, Amber Awad, Adam Grenier, and Deborah Hartley
Sponsored By: Synomics Pharma
Corona charged aerosol detection (CAD®) has become a widely used technology in the pharmaceutical laboratory. This paper examines the operation and use of CAD in a regulated environment, addressing method development and validation specifics. |
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Tracking Unnamed Microorganisms Using DNA Sequences
Authors: Melissa K. Ruch, Sara C. Polson, Jacqueline L. Miller and Douglas H. Smith
Sponsored By: Accugenix, Inc.
Using 16S rDNA sequences for tracking unnamed bacteria, instead of relying on the taxonomic name, is especially useful when only a genus name, or higher level taxa, can be assigned. |
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Nano-Scale Compounding via Hot Melt Extrusion (HME)
Authors: Charlie Martin
Sponsored By: Leistritz
Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of API’s/excipients via extrusion to determine process viability. Experimental data is presented on a new twin screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. |
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Linking CQAs to CPPs in Life Science Manufacturing
Authors:
Randy Tatlock, Senior Application Specialist, Aegis
John Helfrich, Vice President, GMP Automation Programs, VelQuest Corporation
Sponsored By: Aegis Analytical Corp
You’ve identified CPPs & CQAs in your process. Link them unequivocally with cause & effect analysis. Watch our webcast and explore best practices for understanding relationships between CPPs & CQAs. |
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Debunking Myths About Buying Pre-Owned Equipment
Sponsored By: EquipNet, Inc.
In the new eBook, "Purchasing Reality Check," EquipNet debunks common myths about buying pre-owned industrial equipment. Doesn't it make sense to save money where you can without sacrificing quality? |
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How to Respond to (and Avoid) FDA 483s
Authors: 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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Benefits Of Steam System Audits
Authors: Dawn Cartwright Dukes
Sponsored By: Spirax Sarco, Inc.
A clean- or pure-steam system provides the correct quality and purity of steam within operating parameters. A steam-system audit is economically sound, improving operation, safety and environmental stewardship. |
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Clean-In-Place Automation – Glatt Coating Pan
Authors: Torben Anderson
Sponsored By: MORK Process Inc.
This case study covers the implementation of an automated Clean-In-Place system into a Solid Dosage application of a Glatt Coating Pan. This application resulted in the automation of a manual cleaning process while shortening time to clean and improving the quality and consistency of clean. |
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Precise Gas Flow Control: The Sierra Way
Sponsored By: Sierra Instruments
Learn the principle of operations of capillary flow technology by following a molecule of gas through the flow measurement in this new video. |
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Enterprise Level Change Control: A Life Sciences Business Imperative
Sponsored By: Sparta Systems
According to the FDA, "Change control is a complex process. Inadequate change control exposes a company to product liability actions, results in product recalls, causes internal confusion, and is a serious
violation of the Quality System (QS) regulation." This paper reviews the key issues and provides a checklist of key functionality needed for an effective solution.
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Standards & Regulation Category: |
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Challenges to Pharmaceutical Supply Chain Assurance
Author: Mr. Neil Wilkinson
Sponsored By: David Begg Associates (USA) LLC
There is NO single ‘Magic Bullet’ solution to Pharmaceutical Supply Chain Assurance. It needs a holistic approach across multiple areas. Learn how your company can stay on task in 2010. |
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Moisture Activated Dry Granulation using Starch
Author: Carrie Shipley, Susan Freers
Sponsored By: Grain Processing Corporation
Using pregelatinized starch as the absorbent diluent in the Moisture Activated Dry Granulation (MADG) process, combinations of maltodextrin and povidone were tested to determine optimum binder level. |
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Cleanroom Equipment, Garments & Accessories Category |
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Donning by Design
Author: Damon Larkin
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*, KIMTECH* Brand
This paper addresses the importance of process protection in cleanrooms via the appropriate cleanroom suit. It provides an overview of the sterile cleanroom apparel category and defines key areas for improvement. It introduces a new concept for sterile cleanroom gowning to help minimize the problems associated with current technologies. |
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