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  • DSCSA: New Regulations Require Action

    03/22/2017, 10:15 AM - 11:00 AM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Best Practices in Equipment Cleaning & Cleaning Validation: Use of Statistical Tools in Cleaning Validation Lifecycle

    03/22/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

    Presentation “Use of Statistics in Cleaning Validation Lifecycle” proposes a number of statistical tools that help in evaluation of data attained in three stage...

    • Language: English

  • Best Practices in Equipment Cleaning & Cleaning Validation: Cleaning Limits & Visual Inspection from an Analytical Perspective

    03/22/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

      Visual inspection following equipment cleaning is a mandatory step in the cleaning verification workflow for pharmaceutical equipment. Equipment must pass vis...

    • Language: English

  • Smart Manufacturing Enabled by the Connected Enterprise

    03/22/2017, 10:30 AM - 11:00 AM, Meeting Room 5

    Life Science companies face significant challenges to increase operational efficiency, reduce costs, increase quality and manage risk, while improving flexibili...

    • Language: English

  • Best Practices in Equipment Cleaning and Cleaning Validation: A New ASTM Standard for Cleaning Validation

    03/22/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

      This presentation will introduce the“Standard Guide for Science and Risk-based Cleaning Process Development and Validation” a standard guide in the final stag...

    • Language: English

  • Biosafety Considerations for Single Use Technology

    03/22/2017, 10:30 AM - 11:15 AM, Meeting Room 2

    Biosafety Considerations for Single Use Technology

    • Language: English

  • Multi-point Battery-free Wireless Sensors for Aseptic Process Monitoring

    03/22/2017, 10:30 AM - 11:15 AM, Meeting Room 4

    Monitoring product temperature accurately is critical to process development and scale-up related work in the pharma/bio-pharmaceutical industry. Ability to con...

    • Language: English

  • Ensuring Data Integrity Through Quality Systems and Auditing Techniques

    03/22/2017, 10:30 AM - 11:15 AM, Meeting Room 3

    Data integrity is not a new concept, but due to recent FDA Warning Letters and other global compliance actions, it has garnered much focus and needed attention....

    • Language: English

  • DME Facilty Focus: cGMP Facility Modernization: New Solutions for Aging Facilities

    03/22/2017, 10:30 AM - 11:30 AM, Meeting Room 1

    In recent years, disruptive technologies have created a new vision for the cGMP facility of the future- one that offers the promise of improved manufacturing fl...

    • Language: English

  • Regulatory Aspects of Continuous BioProcessing

    03/22/2017, 11:15 AM - 12:00 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Serialization Journey

    03/22/2017, 11:30 AM - 12:15 PM, Meeting Room 2

    TBA

    • Language: English

  • Serialization Best Practices for CMO Onboarding

    03/22/2017, 11:30 AM - 12:00 PM, Meeting Room 5

    This session will discuss serialization best practices and processes to optimize the success of your CMO onboarding plan.

    • Language: English

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