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Sherilyn Campie, M.S.

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August CMC Community meeting

Posted By Sherilyn Campie 08-03-2026 20:59
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
Please join us on Friday, August 14th at 12PM (PST)/3PM(EST) for a round table discussion on the following topics of interest that were highlighted in our July meeting: Setting Specifications (please note that the Quality community is presenting a webinar on Patient Centric Specifications on Aug 13th. ...

Call for Comments - SUPAC guidances

Posted By Sherilyn Campie 04-07-2026 21:25
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
The FDA has announced the establishment of a docket [https://www.federalregister.gov/documents/2026/03/03/2026-04196/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments] to solicit public comment on the following guidances for industry on scale-up and post-approval ...

Welcome to the new CMC Community

Posted By Sherilyn Campie 04-07-2026 13:02
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
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 ...