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IVT's Quality Risk Management: Applications to Design, Validation and Automation that Yield Eye-Opening Results
January 21-23, 2015
Orlando, FL USA



December 11, 2014 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE

News

Continuous Solid-Dosage Manufacturing Platform Nears Prototype Installation
A G-CON, GEA, and Pfizer collaboration developed a PCMM (portable, continuous, miniature, and modular) system to produce oral solid-dosage drugs.
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Outside Looking In
European CDMOs want into the US market, but entry options are limited.
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The Risk and Compliance Paradigm: Risk Management's Impact on QMS
Risk Management is everywhere, and is not some lofty strategic element that is limited to top floor suits making enterprise-wide decisions. Risk Management is becoming an integral part of the compliance process. There are many ways to look at Risk, and each industry has developed different risk based tools to suit their specific business needs.

Get a glimpse at how compliance industries are utilizing risk as a core benchmarking metric for decision-making in the enterprise. Learn more

Using Flow Sensors to Monitor Process System Health
Using flow sensors, operators can monitor compressed-air use to help identify problems early and provides data for improving energy efficiency.
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Advertisement:
Capsugel Bornem
Vcaps® Plus capsules offer better performance compared with first-generation HPMC capsules. Now there is an exciting new way for you to find the right capsule for your specific trial, project, or study needs. the Vcaps® Plus Expert Kit. This complimentary kit offers R&D professionals a fast and comprehensive hands-on experience with Vcaps® Plus technology. Order your free kit now

A Robust CAPA System for a Global Supply Chain
Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
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News

Merck Acquires Cubist Pharmaceuticals
The acquisition will enhance Merck's "superbug" medication portfolio.
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Drug Spending Rises
Spending rises on prescription drugs despite overall slow-down in health care outlays.
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Advertisement:
ATCC® Minis provide a convenient, ready-to-use solution for handling pharmacopeial-recommended strains. ATCC® Minis are authenticated and backed by ATCC polyphasic testing – ensuring the same consistent and reliable reference materials you’ve come to trust from ATCC Genuine Cultures®. Use promo code BST114 to save 15% on ATCC® Minis between now and December 31, 2014 (U.S. only; restrictions apply)! Order now at www.atcc.org/minis

Paragon Bioservices to Scale Up Protein Manufacturing
Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.
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Advertisement:
Maximizing Roller Compaction Benefits with Proper Excipient Selection
Tuesday, December 09, 2014, 10:00 AM Eastern Standard Time
To Register Free: www.pharmtech.com/roller

News

Johnson Matthey Acquires Capacity in Scotland
The Scottish plant was built by Glaxo in 1980 and will be refurbished in 2015.
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Safe and cost-effective capsule filling for pre-clinical and first-in-man studies
Monday, December 15, 2014
Click here to Register free.

Packaging Manufacturer, Sepha, Wins Award for its Non-Destructive Leak Detection Device
Sepha's VisionScan is the first tool-less, non-destructive leak detection device for pharmaceutical blister packs, which uses a camera-imaging technology.
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FDA Issues Draft Guidance to Foster Competitive Access for Bioequivalence Studies
The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.
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Developing a Comprehensive Tool Kit for Microbial Identification
November 18, 2014
Click here to Register free.

EMA Reassures Safety of Novartis Flu Vaccine
No evidence that Fluad vaccine caused deaths in Italy, says EMA.
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FDA Approves Amgen Drug for Acute Lymphoblastic Leukemia
Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.
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Sanofi Faces Alleged Kickback Charges
Sanofi executives are being charged in a whistleblower lawsuit for allegedly granting illicit payments to healthcare providers.
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News
Analytical and Bioanalytical Testing eBook 2014
View technical articles on the best practices and methods for analytical and bioanalytical testing including method transfer during scale up, viral contamination detection, and analytical QbD, as well as a roundup of analytical technology.
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Podcasts
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Pharmaceutical Technology Solid Dosage Combo
Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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