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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 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 »
Published January 14, 2015
Validates MSD V-PLEX 10-plex Proinflammatory Panel Read More »
Trillium Technologies Group Inc.
By Ravi Joshi, Managing Director
High Potency Rebuttal
By Karen Ginsbury; Destin A. LeBlanc, PCI Pharmaceutical Consuting; Cleaning Validation Technologies
Published January 22, 2014
Clarifying the uncertainty remaining in the quest to define “certain” products Read More »
Therapure Biopharma Inc.
By Rajan Puri, Director, Business Development
Therapure Biopharma is a Contract Development and Manufacturing Organization (CDMO) that specializes in the development, scale up and manufacture of complex biologics. Therapure operates a modern 130,000 ft2 cGMP facility in the Greater Toronto Area… Read More »


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