Chemistry, Manufacturing and Controls Community

  • 1.  Welcome to the new CMC Community

    Community Leadership
    Posted 9 days ago
    We are honored to serve as Chair and Vice Chair of the Chemistry, Manufacturing & Controls (CMC) Community and look forward to fostering knowledge sharing and collaboration under this new community structure.
    The CMC community encompasses a broad scope, integrating manufacturing and analytical processes from development through qualification and validation for commercialization, as well as the quality controls that ensure product quality, safety, and efficacy. With the merger of five communities into one, we are excited by the diverse expertise now represented and the many opportunities this creates for engaging discussions and collaboration.
    Our initial goal is to meet with each of the former community leadership and review topics that were of interest and determine which should continue within the unified CMC community. We also aim to partner with other communities on shared interests and develop programming that highlights both CMC-focused topics and the connections between our work and key support functions such as Quality and Regulatory Affairs.
    We look forward to the AAPS Community Forum kick-off meeting this Wednesday and will share details about our first monthly CMC community meeting in the coming weeks.
    We encourage your active participation and contributions as we work together to build a vibrant, collaborative CMC community.
    Sherilyn & Hiten


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    Sherilyn Campie M.S.
    Director, Quality Control
    Accord Biopharma
    Raleigh NC
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Welcome to the new CMC Community

    Community Leadership
    Posted 3 days ago

    Thanks Sherilyn,

    I would like to echo what you mentioned about active participation and contributions.

    Thanks

    Hiten



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    Hiten Gutka
    Chair Sterile Products Community
    Senior Principal Scientist Drug Product Development
    Bristol Myers Squibb
    New Brunswick NJ

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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