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2019 Technical Education Program

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  • A Transformational Living Cell Environment: A Paradigm Shift in Personalized Medicine that Provided the Most Comprehensive Protection Across all Cell Culture/Processing Operations

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    Ongoing research and learnings in In Vitro Fertilization (IVF) programs provide a strong foundation specific to optimizing the in vitro culture environment of t...

    • Language: English

  • Flexible and Efficient Manufacturing Facilities – A Holistic Approach to the Design and Implementation

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    Efficient and flexible facilities are designed with an optimal cost of goods, maximum yield, while maintaining flexibility to support changes in the production ...

    • Language: English

  • FDA and EU GMP Annex 1 Differences of Cleanroom Specification. Is it Not Time to Eliminate Them?

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    This presentation highlights several bullet points: - 5.0 μm particles and a general comparison of EU and FDA approaches to cleanroom specification/testing; cri...

    • Language: English

  • Continuous Aseptic Manufacturing Using Spray Freeze Drying: Equipment, Process and Product Considerations

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    Freeze drying has traditionally been a batch process making it both time consuming and energy intensive. While the use of new process analytical technology has ...

    • Language: English

  • Single-Use System Supports a Freeze/Thaw Platform Capable of Providing an End-to-End Solution for Fluid Drug Substance Inter-Facility Storage and Delivery

    04/02/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    The inter-facility management of freeze/thaw processes of drug substances has been a challenge fraught with issues that affect sites around the globe. Drug manu...

    • Language: English

  • In-Line Monitoring and Real-Time-Release

    04/02/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall

    The BioPhorum Technology Roadmap team, consisting of multiple end-user and supplier companies published a Biomanufacturing Technology Roadmap in July 2017. As ...

    • Language: English

  • Innovative RAPA: "Risk Analysis & Preventive Actions" Approach. Case Study of OSD High Potent (OEL1 to OEL5) Facilities Design Meeting cGMP & HSE Requirements

    04/02/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    Risks management represent an essential step in the process validation implementation during all the life cycle of a given pharmaceutical plant from its concept...

    • Language: English

  • Innovative GAPA: "Gap Analysis & Preventive Actions" Design Approach. Case Study – cGMP Sterile Facilities Design New Trends Involving Continuous Process Validation Guidelines (FDA2011)

    04/02/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - Stage 1, Booth 1076, Exhibit Hall

    About 45% of drug and device recalls are due to design issues. These defects represent the main source of risks that, if furthermore neglected, can trigger sign...

    • Language: English

  • Exploring a Blockchain Enabled Supply Chain

    04/02/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    Despite the billions being invested in protecting products and securing the supply chain, we are not seeing a material decrease in issues. The gray market is s...

    • Language: English

  • A Risk Based Approach for Cleaning and Disinfection Program

    04/02/2019, 4:15 PM - 5:15 PM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    The presentation presents and analyzes the different regulatory requirements related to cleaning and disinfection program. The presentation discusses the differ...

    • Language: English

  • Walking Through a Practical Energy Conservation Program (ISO50001) Using an IoT Technology for Compressed Air Usage at a Large Pharma Facility

    04/03/2019, 10:00 AM - 10:45 AM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    ISO50001 is a guideline for manufacturers to reduce energy consumption. Pharma end users adopt this program to improve environmental impact & reduce utility co...

    • Language: English

  • It's the Climb: Scaling the Digital Transformation Mountain One Step at a Time

    04/03/2019, 11:00 AM - 11:45 AM, Javits Conventions Center - Stage 3, Booth 1877, Exhibit Hall

    You've heard the buzzwords: digital transformation.....digitization....Industry 4.x......but what are some practical approaches to achieving the promised benef...

    • Language: English

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