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  • Packaging Validation: E&L Detection

    Packaging Validation: E&L Detection

    Kurt L. Moyer and James R. Scull, NSF Health Sciences || November 13, 2013
    Improve patient safety and avoid costly product-launch delays

  • Implementing Process Validation Guidances

    Implementing Process Validation Guidances

    Peter H. Calcott, Ph.D., President, Calcott Consulting LLC || March 6, 2013
    Complying with FDA and EU for small and mid-sized companies

  • A Novel Tool for Cleaning Validation

    Makarand (Mak) Jawadekar, Contributing Editor || May 30, 2012
    Light Induced Fluorescence Technology

  • Aseptic Processing Validation

    Aseptic Processing Validation

    Ross Acucena and Randy Wilkins || April 4, 2012
    Best practices for sterile filtration validation of re-use and extended-use processes

  • Process Validation

    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.…

  • Validation

    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…

  • Validation batches

    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.…