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2019 Technical Education Program

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  • The Evolution of EBR: Augmented Batch Records

    04/02/2019, 10:30 AM - 11:15 AM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    As EBR evolves, Augmented Bath Records will elevate and empower an organization's human workforce. Organizations can augment existing content, execute on any de...

    • Language: English

  • S.T.A.R. (Systematic Transition to Quality and Risk) WARS: May the Interface be With You!

    04/02/2019, 11:30 AM - 12:15 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    During product planning, you must acknowledge the uncertainty associated with the risks in your operating climate. Assessing these risks and how they manifest i...

    • Language: English

  • Four Steps To Safer, More Reliable Biomanufacturing

    04/02/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    This paper will present the industry collaborations that have formed to address concerns about supply chain management, particulates, extractables, system integ...

    • 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

  • 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

  • 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

  • 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

  • Cyber Resilience – Ensuring Your Infrastructure Can Withstand Adverse Events and Attacks Without Jeopardizing Productivity

    04/03/2019, 11:00 AM - 11:45 AM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    As pharmaceutical production processes become more connected than ever, the risk of major disruption to production also escalates. Acts of nature and cyber att...

    • Language: English

  • Rethinking Cleaning Validation for API Manufacturing

    04/03/2019, 1:15 PM - 2:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    Cleaning validation is a regulatory requirement around the world and an integral step within the manufacturing of active pharmaceutical ingredients (APIs). The ...

    • Language: English

  • Cleaning Cycle Development for Parts Washers

    04/03/2019, 2:15 PM - 3:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    Parts washers provide efficient cleaning of various materials and components utilized in the biotechnology and pharmaceutical manufacturing process industries, ...

    • Language: English

  • Quality Systems - It's a "Risky" Business

    04/03/2019, 3:15 PM - 4:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    Many, if not all organizations want to reduce their risks to as low as reasonably practicable (ALARP concept). The biggest question is how and where is the ris...

    • Language: English

  • Critical Utilities Support of Continuous Manufacturing - The Keys to Success

    04/03/2019, 4:15 PM - 5:00 PM, Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

    Continuous manufacturing relies heavily on proper planning and design. All support utilities must be capable of being continuously available on the same schedu...

    • Language: English

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