Quality Risk Management

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A Case Study in Application of the Risk Knowledge Infinity Cycle
Peer Schmidt, Martin J. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen and Kevin O’Donnell

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 367-383; DOI: https://doi.org/10.5731/pdajpst.2023.012931
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Interventions Risk Evaluation and Management in Aseptic Manufacturing
Hal Baseman, Subrata Chakraborty and Michael A. Long

PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 485-496; DOI: https://doi.org/10.5731/pdajpst.2020.012245
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Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239
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A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control
Cleyton Lage Andrade, Miguel Angel De La O Herrera and Elezer Monte Blanco Lemes

PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 317-331; DOI: https://doi.org/10.5731/pdajpst.2016.007286
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Development of a Premium Quality Plasma-derived IVIg (IQYMUNE^®) Utilizing the Principles of Quality by Design—A Worked-through Case Study
Philippe Paolantonacci, Philippe Appourchaux, Béatrice Claudel, Monique Ollivier, Richard Dennett and Laurent Siret

PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 176-187; DOI: https://doi.org/10.5731/pdajpst.2016.007393
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A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. Menezes

PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
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Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry

PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
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2015/2016 Quality Risk Management Benchmarking Survey
Kelly Waldron, Emma Ramnarine and Jeffrey Hartman

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 330-345; DOI: https://doi.org/10.5731/pdajpst.2017.007526
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The Reliability-Quality Relationship for Quality Systems and Quality Risk Management
H. Gregg Claycamp, Faiad Rahaman and Jason M. Urban

PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 512-517; DOI: https://doi.org/10.5731/pdajpst.2012.00888
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Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas
Tim Sandle

PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 560-579; DOI: https://doi.org/10.5731/pdajpst.2012.00891

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Quality Risk Management

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Parenteral Drug Association, Inc.