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Aseptic Validation in Single-Use Technology
By Richard Bhella and Vishwas Pethe, ATMI LifeSciences
Published April 3, 2013
A new testing process may improve results Read More »
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 »
By Makarand (Mak) Jawadekar, Contributing Editor
Published May 30, 2012
Light Induced Fluorescence Technology 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 »
Published February 27, 2012
Validation batches are commercial scale batches that are manufactured consecutively in order to validate a process according to a validation protocol that was developed and authorized.… Read More »
Quality by Design: Product & Process Development
By Dr. Siegfried Schmitt
Published November 14, 2011
Product & Process Development Read More »
Increased FDA Scrutiny of Purchasing / Supplier Controls
By Braulio Ortiz, Michael Neaves
Published October 8, 2010
Multiple perspectives on shifting regulatory burdens Read More »
Is Three-Batch Validation Obsolete?
By John Avellanet
Published September 1, 2010
Where is the new process validation guidance leading us? Read More »
Aseptic Process Validation
By Tom Spurgeon
Published November 3, 2006
Is a new FDA guidance imminent? Read More »
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