Document (1-4 of 4)

1. Innovation and Continuous Improvement in Pharmaceutical Manufacturing

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   Document | 28 Mar 2024 | Contributor(s):: Ajaz Hussain (Chairperson) Raafat Fahmy (CVM), William Bargo (CVM), Robert Coleman, Robert (ORA), Elise Murphy (ORA), Frank Holcombe Jr (CDER), Chris Watts (CDER), See Lam (CDER), Jon Clark (CDER), Christopher Joneckis (CBER), John Dietrick (CDER), Diana Kolaitis (ORA), Vilayat Sayeed (CDER), Mai Huynh (CVM), Norman Schmuff (CDER), Andrew Chang (CBER)

   The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century

2. The Process Analytical Technology Initiative: PAT and the Pharmacopeias

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   Document | 28 Mar 2024 | Contributor(s):: Ajaz S. Hussain

   The PAT Initiative A part of the Pharmaceutical Quality for the 21st Century Initiative  PAT and the USP Opportunities for the USP to support the PAT Framework

3. The Regulatory Landscape Regarding Continuous Manufacturing

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   Document | 17 Aug 2023 | Contributor(s):: Adam Fisher

4. Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing

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   Document | 17 Aug 2023 | Contributor(s):: Riley C. Myers