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- Published online June 18, 2018.
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- previous version (April 18, 2018 - 16:57).
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© PDA, Inc. 2018
Author Information
- Emma Ramnarine* and
- Kevin O'Donnell
- Sr. Director, Head Global Analytical Science and Technology, Genentech/Roche
- Market Compliance Manager, Health Products Regulatory Authority (HPRA)
- ↵* 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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- 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
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