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Last Updated Wednesday, October 22 2014
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Implementing Process Validation Guidances
By Peter H. Calcott, Ph.D., President, Calcott Consulting LLC
Published March 6, 2013
Complying with FDA and EU for small and mid-sized companies Read More »
Aseptic Processing Validation
By Ross Acucena and Randy Wilkins
Published April 4, 2012
Best practices for sterile filtration validation of re-use and extended-use processes Read More »
Published February 27, 2012
Establishing, through documented evidence, a high degree of assurance that a specific process will consistently yield a product that meets predetermined specifications and quality characteristics.… Read More »
Aseptic Process Validation
By Tom Spurgeon
Published November 3, 2006
Is a new FDA guidance imminent? Read More »
AbbVie Contract Manufacturing
By Michelle Calhoun, Director of Sales and Marketing, Commercial Operations
AbbVie, world leader in pharmaceuticals, provides Contract Manufacturing Services that span API manufacturing, biologics, potent drugs, finishing and packaging of pharmaceutical drug products. Our vast network of global manufacturing facilities allow… Read More »
Dequantify Yourself
By Rick Piazza, Medidata
Published November 13, 2013
Are all those system metrics your friend or foe? Read More »
UPM Pharmaceuticals, Inc.
By Mike Raum, Sales Administrator
UPM Pharmaceuticals is a contract research and manufacturing organization specializing in solid dosage formulations. We offer remarkably flexible, affordable, and rapid outsourcing services designed to meet our clients’ development and manufact… Read More »
Rottendorf Pharma GmbH
By Rottendorf Pharma GmbH
Rottendorf Pharma is a worldwide operating Technical Operations Organization for development, manufacturing and packaging of solid dosage forms. We offer the complete range of services according to customer needs assuming Total Process Ownership on e… Read More »
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