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Research ArticlePDA Papers

Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction

Emma Ramnarine and Kevin O'Donnell
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 338-345; DOI: https://doi.org/10.5731/pdajpst.2017.008524
Emma Ramnarine
Sr. Director, Head Global Analytical Science and Technology, Genentech/Roche
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  • For correspondence: eramnar@gene.com
Kevin O'Donnell
Market Compliance Manager, Health Products Regulatory Authority (HPRA)
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Article Information

vol. 72 no. 3 338-345
DOI 
https://doi.org/10.5731/pdajpst.2017.008524
PubMed 
29669814

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online June 18, 2018.

Article Versions

  • previous version (April 18, 2018 - 16:57).
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Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Emma Ramnarine* and
  2. Kevin O'Donnell
  1. Sr. Director, Head Global Analytical Science and Technology, Genentech/Roche
  2. Market Compliance Manager, Health Products Regulatory Authority (HPRA)
  1. ↵* Corresponding Author: Emma Ramnarine, Senior Director, Head Global Biologics QC, Genentech/Roche, 1 DNA Way, South San Francisco, CA 94080. E-mail: eramnar{at}gene.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 3
May/June 2018
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Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
Emma Ramnarine, Kevin O'Donnell
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 338-345; DOI: 10.5731/pdajpst.2017.008524

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Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
Emma Ramnarine, Kevin O'Donnell
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 338-345; DOI: 10.5731/pdajpst.2017.008524
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  • Article
    • Abstract
    • Introduction
    • Practical Implications
    • Risk Management and Knowledge Management
    • Role of the Pharmaceutical Quality System (PQS)
    • Estimation of Risk Reduction
    • Change Management and Risk Reduction
    • Enabling Regulatory Flexibility through an Effective PQS
    • Risk Management Learnings from Other Industries
    • Conflict of Interest Statement
    • Reference
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