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    Online Exclusives

    Notes From DCAT Week ’15

    Program objectives and challenges for the FDA’s Quality Metrics Initiative

    Notes From DCAT Week ’15
    Notes From DCAT Week ’15
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    Kristin Brooks, Contract Pharma03.25.15
    DCAT Week ’15, organized by the Drug, Chemical & Associated Technologies Association, was held March 16-19, at the Waldorf Astoria in New York. The event hosted pharma/biopharma companies, service providers and member companies, and the hotel lobby was buzzing with meetings throughout the event. Also, several sessions addressed key industry topics, namely, the FDA’s Quality Metrics initiative. Below are some session highlights along with an interview on API sourcing trends.
     
    The session entitled “Quality Metrics: The FDA's Initiative and Its Impact on Pharma Manufacturers and Suppliers,” addressed the latest progress on the FDA’s quality metrics initiative and its impact on pharma manufacturing. Speakers included: Alex Viehmann, Statistician, Center for Drug Evaluation and Research / Office of Surveillance, Quality Intelligence Branch, U.S. FDA, and Frances Zipp, President, Lachman Consultants.
     
    The FDA continues to place an emphasis on surveillance for now, but will develop and manage an analytics and prediction progr

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