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FDA Compounding Quality Center of Excellence Annual Conference 2025

    August 25, 27, 28, 2025

     

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    Pre-Conference: Facility Design and Preparation

    The Journey to Build a Sterile Drug Product Facility
    Lesson 1 of 4 within section Pre-Conference: Facility Design and Preparation.
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    Q&A Session 1-1 (FDA Compounding Conference 2025)
    Lesson 2 of 4 within section Pre-Conference: Facility Design and Preparation. You must enroll in this course to access course content.
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    503B Pre-Operational Evaluations: A First Step to Compliance
    Lesson 3 of 4 within section Pre-Conference: Facility Design and Preparation.
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    Q&A Session 1-2 (FDA Compounding Conference 2025)
    Lesson 4 of 4 within section Pre-Conference: Facility Design and Preparation. You must enroll in this course to access course content.
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    Day One: Wednesday, August 27, 2025

    Welcome & Opening Remarks (FDA Compounding Conference 2025)
    Lesson 1 of 9 within section Day One: Wednesday, August 27, 2025.
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    Meeting Patient Needs Through the Years (FDA Compounding Conference 2025)
    Lesson 2 of 9 within section Day One: Wednesday, August 27, 2025.
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    Customer Perspective: Initial Evaluation of an Outsourcing Facility (FDA Compounding Conference 2025)
    Lesson 3 of 9 within section Day One: Wednesday, August 27, 2025.
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    Drug Shortage Mitigation by Outsourcing Facilities
    Lesson 4 of 9 within section Day One: Wednesday, August 27, 2025.
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    Customer Perspective: Ongoing Evaluation of an Outsourcing Facility
    Lesson 5 of 9 within section Day One: Wednesday, August 27, 2025.
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    Visual Inspection (FDA Compounding Conference 2025)
    Lesson 6 of 9 within section Day One: Wednesday, August 27, 2025.
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    End-to-End Production of a Drug in Shortage by Outsourcing Facilities
    Lesson 7 of 9 within section Day One: Wednesday, August 27, 2025.
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    Stability Studies and Validation (FDA Compounding Conference 2025)
    Lesson 8 of 9 within section Day One: Wednesday, August 27, 2025.
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    Media Fills (FDA Compounding Conference 2025)
    Lesson 9 of 9 within section Day One: Wednesday, August 27, 2025.
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    Day Two: Thursday, August 28, 2025

    Establishing Standardized Formulations (FDA Compounding Conference 2025)
    Lesson 1 of 11 within section Day Two: Thursday, August 28, 2025.
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    Drug Enforcement Administration (DEA) Quota Essentials for Outsourcing Facilities
    Lesson 2 of 11 within section Day Two: Thursday, August 28, 2025.
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    USP General Chapters and Outsourcing Facilities (FDA Compounding Conference 2025)
    Lesson 3 of 11 within section Day Two: Thursday, August 28, 2025.
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    Deep Dive into 483 Observations
    Lesson 4 of 11 within section Day Two: Thursday, August 28, 2025.
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    Wholesaling Guidance Highlights (FDA Compounding Conference 2025)
    Lesson 5 of 11 within section Day Two: Thursday, August 28, 2025.
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    Meeting Patient Needs for the Future (FDA Compounding Conference 2025)
    Lesson 6 of 11 within section Day Two: Thursday, August 28, 2025.
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    Closing Remarks (FDA Compounding Conference 2025)
    Lesson 7 of 11 within section Day Two: Thursday, August 28, 2025.
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    Meeting the Needs of Special Populations (FDA Compounding Conference 2025)
    Lesson 8 of 11 within section Day Two: Thursday, August 28, 2025.
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    Immediate-use Syringes and the Risks of Extended Use (FDA Compounding Conference 2025)
    Lesson 9 of 11 within section Day Two: Thursday, August 28, 2025.
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    Cleanroom Gowning: 5 Common Mistakes and How to Address
    Lesson 10 of 11 within section Day Two: Thursday, August 28, 2025.
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    Introduction to Water Systems (FDA Compounding Conference 2025)
    Lesson 11 of 11 within section Day Two: Thursday, August 28, 2025.
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    About This Course

    FDA’s Compounding Quality Center of Excellence hosted its sixth Annual Conference, August 27 and 28, 2025. The conference convened outsourcing facilities, pharmacy compounders and others from across the industry to discuss emerging trends and best practices through presentations, panels and interactive sessions.

    Course Information

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