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2018 Technical Education Program

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  • Integrating a Programmable Robotic Bioreactor System with a Biochemical Analyzer for Real-time Analysis

    04/17/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    High-throughput bioreactor robotic systems have started to replace traditional, labor and time intensive methods of using shake flasks and stirred tank reactors...

    • Language: English

  • 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

  • Start-ups – Moving out of the Incubator into a New Pilot/Manufacturing Facility

    04/17/2018, 1:30 PM - 2:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Start-up companies often have their beginnings in a crowded flex space. After years of research and testing, they finally developed a viable product. This is ...

    • Language: English

  • Optimized Manufacturing of mAb-based Products: Flexibility, Speed, and Efficiency can Co-exist

    04/17/2018, 2:30 PM - 3:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    The manufacture of mAb-based products represents a large portion of many company's drug substance pipeline. In order to ensure that critical business goals focu...

    • 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

  • Process Economics: The Driving Force behind the Criteria for Cell Therapies Facility Design

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Today's small number of approved cellular therapy products (13 FDA-approved), a large number of clinical trials (>10,000), and favorable regulatory climate, as ...

    • 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

  • 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

  • The Theory Behind Automatic Inspection Technologies for Subvisible-to-Visible Particle Detection and Container Closure Integrity

    04/19/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Increased quality compliance is a challenge best addressed with well-developed concepts and valuable industry experience. This presentation will take a deep div...

    • Language: English

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