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2018 Technical Education Program

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  • 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

  • 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

  • Lessons learned from microbial contamination in pharmaceutical manufacturing –Benefit of end user and supplier collaboration

    04/18/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    The audit remarks related to inadequate microbial contamination control and the investigation of discrepancies from 2014 and 2015 by the FDA auditors are increa...

    • Language: English

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