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2018 Technical Education Program

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  • Bioprocess Simulations – the means to decision making from Feasibility through Detailed Design

    04/17/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Speed to market continues to be a critical need for pharmaceutical companies expanding and/or launching new products to the marketplace. Whether it's deploying ...

    • Language: English

  • Cleaning Validation – Different approaches to limit setting for detergents

    04/17/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Cleaning validation projects involve a lot of different departments and resources within pharmaceutical manufacturing. One of the most critical steps within th...

    • Language: English

  • Remediation Challenges of Aging Facilities

    04/17/2018, 1:30 PM - 2:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Aging is an unavoidable part of a facility's life cycle. It is imperative that the facility owner constantly evaluate the impact of aging to the prime purpose ...

    • Language: English

  • On-dose identification for tablets and capsules – dosage design and equipment innovation to mitigate risks in patient safety and brand protection

    04/17/2018, 2:30 PM - 3:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Many business needs can be satisfied by providing unique identification on solid oral dosage forms. But there is truly only one purpose: patient safety. Manag...

    • Language: English

  • Risk analysis: Present state and industry's demand

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Risk analysis: Present state and industry's demand Dr. A. Fedotov, Clean Technologies LLC, Moscow, Russia 1. ICH Q9/EU GMP on risk analysis – are they correct ...

    • Language: English

  • Settling the Frontier of Fill-Finish Operations – High Tech Filling in a Proper Abode

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Fill/finish operations represent perhaps the last frontier of significant risk in manufacturing injectable medicines. Closed systems in compounding and formulat...

    • 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

  • Cleaning Agent Screening: Key Aspects in Selecting a Suitable Cleaning agent for a GMP Cleaning Procedure

    04/18/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    The recent shift from traditional cleaning validation to a cleaning life cycle approach emphasizes the requirement for scientifically sound decisions in the des...

    • Language: English

  • Verifiable Containment Performance of Isolator Technologies

    04/18/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    With the advent of increasingly potent compounds such as HPAPIs, ADCs, etc within the pharmaceutical industry, the focus on containment solutions and their abil...

    • Language: English

  • Harmonized Method for Cleanroom Hard Surface Disinfectant Efficacy Evaluations

    04/18/2018, 1:15 PM - 2:00 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Disinfectant efficacy validation testing can be a daunting task as there are various factors to consider. There are a number of standardized test methods availa...

    • Language: English

  • A Comprehensive Approach to Cleanroom Certification for Reduced Risk of Environmental Contamination and Improved Regulatory Compliance

    04/18/2018, 3:15 PM - 4:00 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Cleanrooms are an essential part of the manufacturing process used in the production of sterile drugs and medical devices. Maintaining this sterile environment...

    • Language: English

  • Bridging the Gap Between Rinse Water Analysis and Surface Cleanliness

    04/18/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Regulated companies which use automated cleaning applications have always struggled with demonstrating final rinse water quality or visually clean to surface cl...

    • Language: English

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