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2020 Technical Education Program

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  • Risk Mitigation for Higher Levels of Data Integrity

    04/28/2020, 11:30 AM - 12:15 PM, Stage 4, Booth 2276, Exhibit Hall

    Many of us are placing a high focus on data integrity within our businesses. This is especially true for those involved in the manufacture of pharmaceutical an...

    • Language: English

  • Cell & Gene Therapy: The Challenges in Transitioning From Clinical to Commercial Manufacturing/Operational Readiness

    04/28/2020, 11:30 AM - 12:15 PM, Stage 2, Booth 1577, Exhibit Hall

    As of late 2019, there are currently over 400 Cell & Gene Therapy companies in the US, nearly 400 therapies in Clinical Trials and over 800 IND applications sub...

    • Language: English

  • Quality by Design (QbD) in the Era of Cell and Gene Therapy: Taking it to the Next Level

    04/28/2020, 4:15 PM - 5:00 PM, Stage 3, Booth 1877, Exhibit Hall

    Since the publication of ICH-8 in 2006, Quality by Design (QbD) has been employed by the life science industry to improve pharmaceutical product quality, reduce...

    • Language: English

  • A Tactical Blueprint for Regulatory Inspection Readiness

    04/29/2020, 11:30 AM - 12:15 PM, Stage 2, Booth 1577, Exhibit Hall

    This is a practical, detailed training in the How, Where, Who, and What to prepare for an upcoming regulatory inspection. Within minutes of the knock on the doo...

    • Language: English

  • Quality Systems Guidelines: Do they Always give a Clear Way to Assure Quality? Suggestions to Improve

    04/29/2020, 2:15 PM - 3:00 PM, Stage 3, Booth 1877, Exhibit Hall

    The presentation highlights several bullet points: - Do present regulations/guidelines on Quality systems give clear scheme for practical work or they are too w...

    • Language: English

  • A Possible Science-based Approach for Preventive Derouging and Passivation Program

    04/29/2020, 2:15 PM - 3:00 PM, Stage 4, Booth 2276, Exhibit Hall

    The presentation seeks to propose a predictive approach for preventive derouging and passivation program. In this regard, the presentation discusses the possibl...

    • Language: English

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