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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 »
By Shamik Pandit
Published August 23, 2005
How the DOE approach can smooth the process Read More »
By Kevin McCarthy, Associate Director, Sales & Marketing
Hospira One 2 One
By Constantin Loghinov, Marketing Manager Global
Proven Worldwide Experience Put the success of our comfort zone to work for you here, there, anyw… Read More »
Cook Pharmica LLC
By Business Development
Cook Pharmica is a fully-integrated contract development and manufacturing organization (CDMO) that provides biopharmaceutical companies with a unique one-source, one-location model for their product development and manufacturing needs. We simplify o… Read More »
Catalent Pharma Solutions
By n/a
Catalyst + Talent. Our name combines these ideas. Catalent is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics and consumer healt… Read More »
By Gary Selander, Director, Business Development
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