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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 »
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 »
By Katherine Lee
Halo Pharmaceutical
By Nicole Bakaj, Client Service Coordinator
Halo Pharma is a CMO that provides Pharmaceutical Development and Commercial Manufacturing services to help customers bring their products to market quickly and effectively. Halo provides fully integrated capabilities in tablets, capsules, powders, l… Read More »
By Merita Day, Office Manager USA
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