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Last Updated Wednesday, December 17 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 »
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 an analytical method will consistently yield results that accurately reflect the quality characteristics of the product tested.… 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 »
Is Three-Batch Validation Obsolete?
By John Avellanet
Published September 1, 2010
Where is the new process validation guidance leading us? Read More »
Compliance Insight, Inc.
By Cynthia Ipach, President
Compliance Insight, Inc. specializes in hands-on FDA Regulatory and Quality Assurance consulting and training for the pharmaceutical, dietary supplement, medical device, chemical, cosmetics, bio-technology and food industries worldwide. Services incl… Read More »
By Gareth Davies, Sales&Marketing Director
Dales Pharmaceuticals provides a comprehensive range of pharmaceutical services including formulation development, analytical methods development, validation and stability testing plus contract manufacturing and packing. Dosage forms produced include… Read More »
By Emil Ciurczak, Consultant, DoraMaxx Consulting
Published April 9, 2014
Pharmaceutical operations, of all kinds, are simply too complex to rely on univariate thinking Read More »
Published March 18, 2014
Filling your potential Precise manufacturing. Creative thinking. It takes both to succeed in a competitive marketplace. Vetter Commercial Manufacturing supports your injectable with more than 25 years of expertise in high-quality, state-of-the-art as… Read More »

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