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PDA Journal of Pharmaceutical Science and Technology

Advanced Search

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ICH Q10

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    Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide
    Anders Vinther, Fanzia Mohammed and Emma Ramnarine
    PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 454-457; DOI: https://doi.org/10.5731/pdajpst.2021.012627
  • You have access
    Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap
    Martin J. Lipa, Anne Greene and Nuala Calnan
    PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 64-90; DOI: https://doi.org/10.5731/pdajpst.2020.011825
  • You have access
    Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
    Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello Colao
    PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734
  • You have access
    Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management
    Anders Vinther and Emma Ramnarine
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 517-521; DOI: https://doi.org/10.5731/pdajpst.2019.010827
  • You have access
    Quality Risk Management Competency Model—Case for the Need for QRM Competencies
    Ghada Haddad and Anne Greene
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 331-344; DOI: https://doi.org/10.5731/pdajpst.2019.009944
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    The Changing Role of Quality Assurance in the Pharmaceutical Industry
    Robert G. Kieffer
    PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 313-319; DOI: https://doi.org/10.5731/pdajpst.2014.00987

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