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2018 Technical Education Program

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  • Cleaning Validation – Different approaches to limit setting for detergents

    04/17/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Cleaning validation projects involve a lot of different departments and resources within pharmaceutical manufacturing. One of the most critical steps within th...

    • Language: English

  • CRB Tech Tank: Flexible Manufacturing - Adapt or Die!

    04/17/2018, 1:30 PM - 2:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Your business has to be flexible to survive and thrive. A flexible facility tailored to the business needs of your company will save you money. A flexible facil...

    • Language: English

  • CRB Tech Tank: Keep 'em separated! Integrating segregation for gene vector production

    04/17/2018, 2:30 PM - 3:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Don't wait until your facility is overrun! Come learn how CRB approaches effective strategies for segregation of viral vector production, as found in gene thera...

    • Language: English

  • CRB Tech Tank: Solving demand allocation problem with modeling and simulations

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    For a multi-site organization, allocating demands can be a challenging problem. Computer simulations, in conjunction with mathematical modeling, can be used to ...

    • Language: English

  • Case Study: Capacity Expansion and Conversion to Single-Use BioProcessing at an Existing cGMP CDMO Facility

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    With growing demand in the biologics CDMO market, Merck KGaA (Darmstadt, Germany) elected to expand capacity at its existing cGMP biomanufacturing facility in M...

    • Language: English

  • Continuous OSD: Designing a Controls Model

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Continuous processing holds the promise of revolutionizing our approach to manufacturing and quality, but that promise is based on having a fully developed proc...

    • Language: English

  • Cleaning Agent Screening: Key Aspects in Selecting a Suitable Cleaning agent for a GMP Cleaning Procedure

    04/18/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    The recent shift from traditional cleaning validation to a cleaning life cycle approach emphasizes the requirement for scientifically sound decisions in the des...

    • Language: English

  • Current trends & considerations for drug delivery device assembly of self-administered products

    04/18/2018, 3:15 PM - 4:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    A) Post device selection POP (proof of principle) and process development considerations Once the delivery device(s) has been determined for the final deliver...

    • Language: English

  • Case studies : Steam sterilization regulatory requirements, and end user impact analysis and common mistakes.

    04/19/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    The goal is to highlight the links between the different regulatory updates regarding steam sterilization management, validation and requalification. In particu...

    • Language: English

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