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  • Process Validation

    Process Validation

    Peter H. Calcott , Calcott Consulting LLC || October 7, 2015
    Has it changed since the issuance of the FDA and EMA guidances?

  • Validation, Qualification and Calibration

    Validation, Qualification and Calibration

    Marco Benvenuti, Business Manager, SGS Life Science Services Italy || October 7, 2015
    What should a pharma company look for in an outsourcing partner?

  • 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

  • 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.…