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Last Updated Monday, March 30 2015

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Packaging Validation: E&L Detection
By Kurt L. Moyer and James R. Scull, NSF Health Sciences
Published November 13, 2013
Improve patient safety and avoid costly product-launch delays 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 an analytical method will consistently yield results that accurately reflect the quality characteristics of the product tested.… 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
The establishment of documented evidence (for example, data derived from rigorous testing) that provides a high degree of assurance that a specific process or system will consistently yield a product meeting predetermined specifications and quality a… 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 »
Jump Starting the Non-Profit Research Engine
By Kate Hilyard , Managing Director, BioFocus
Published January 29, 2015
How CROs are teaming up with disease foundations to accelerate drug discovery. 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 »


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