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Deep Dive into 483 Observations



    About:

    Explore Form FDA 483 observations to understand common issues and potential pitfalls.

    Presenter:

    June Page
    Manufacturing Quality Compounding Expert
    FDA

    CDR June Page is a Team Lead, Manufacturing Quality Compounding Expert and Senior Regulatory Officer at FDA within CDER’s Office of Compounding Quality and Compliance, Division of Compounding I. She also serves as the Data Integrity Subject Matter Expert within OCQC. CDR Page has served on several instructor-led and web-based trainings, which are available through the Compounding Quality Center of Excellence.

    Prior to joining CDER in 2020, CDR Page served as a Drug Specialist with the FDA’s Office of Regulatory Affairs, Office of Pharmaceutical Quality Operations. Before beginning her tenure at the FDA, she worked as a pharmacist with both Indian Health Service and the Center for Medicare & Medicaid. CDR Page is board certified in Compounded Sterile Preparations Pharmacy. She received her Doctor of Pharmacy degree from South University and her Master’s in Public Health from George Washington University.

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