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2018 Technical Education Program


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  • Data Integrity and Management in the Pharmaceutical Industry. Understanding and Complying with GMP & FDA requirements.

    04/17/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    ♦Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually. Modern data management s...

    • Language: English

  • Data-driven Control Strategy for Critical Drug Container Closure Systems (CCS) Performance at Digital Age

    04/18/2018, 12:00 AM - 1:00 AM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    The container closure integrity (CCI) performance is essential for drug product quality throughout the entire sealed drug product life cycle, and it is predomin...

    • Language: English

  • DME Facility Focus 1: Flexibility by Design: GMP Manufacturing for the Diverse Product Portfolio

    04/18/2018, 10:30 AM - 11:30 AM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    GMP facilities are increasingly challenged to accommodate production diversity, adapt to evolving business needs, and deliver high quality products with low cos...

    • Language: English

  • DME Facility Focus 2: Restrictive Access Barriers: Best industry practices for retrofitting a legacy filling lines with a RABS barrier.

    04/18/2018, 1:00 PM - 2:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Many long-time manufacturers of sterile drug products will eventually wrestle with the "RABS versus Isolator" decision, which is, whether to build new isolator-...

    • Language: English

  • DME Facility Focus 3: Central Utilities for GMP Manufacturing: A Practical Dialog on Cost and Reliability

    04/18/2018, 2:15 PM - 3:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Robust central utility systems are essential to every successful GMP operation. They don't receive the same level of attention typically given to the advanced...

    • Language: English

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