Accelerating Diagnostics in a Time of Crisis The Response to COVID-19 and a Roadmap for Future Pandemics
Book contents
- Accelerating Diagnostics in a Time of Crisis
- Accelerating Diagnostics in a Time of Crisis
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Preface
- Acknowledgments
- Introduction
- Chapter 1 Early Detection, Response, and Surveillance of the COVID-19 Pandemic Crisis
- Chapter 2 Immunology of COVID-19 and Ineffective Immunity
- Chapter 3 Clinical Management: A Roadmap Based on One New York City Hospital’s Response to the COVID-19 Pandemic
- Chapter 4 Contribution of RADx® Tech to the Rapid Development of COVID-19 Diagnostic Tests
- Chapter 5 Coordination of Resources for the Manufacturing and Deployment of COVID-19 Diagnostic Assays
- Chapter 6 Quality and Risk Management Processes for Diagnostic Assays during an Emergency Pandemic Response
- Chapter 7 Development of Assays to Diagnose COVID-19
- Chapter 8 Laboratory Verification and Clinical Validation of COVID-19 Diagnostic Assays
- Chapter 9 Importance of Timely Sequencing, Tracking, and Surveillance of Emergent Variants
- Chapter 10 The RADx® Regulatory Core and Its Role in COVID-19 Emergency Use Authorizations
- Chapter 11 Commercialization and Market Assessment of COVID-19 Assays
- Chapter 12 Testing Strategies to Mitigate COVID-19 Disease Spread
- Chapter 13 A Pandemic Not Just of Infection but of Inequality: The Social Impact of COVID-19
- Chapter 14 Summary and Path Forward for Future Pandemics
- Index
- References
Chapter 6 - Quality and Risk Management Processes for Diagnostic Assays during an Emergency Pandemic Response
Published online by Cambridge University Press: 06 January 2024
Book contents
- Accelerating Diagnostics in a Time of Crisis
- Accelerating Diagnostics in a Time of Crisis
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Preface
- Acknowledgments
- Introduction
- Chapter 1 Early Detection, Response, and Surveillance of the COVID-19 Pandemic Crisis
- Chapter 2 Immunology of COVID-19 and Ineffective Immunity
- Chapter 3 Clinical Management: A Roadmap Based on One New York City Hospital’s Response to the COVID-19 Pandemic
- Chapter 4 Contribution of RADx® Tech to the Rapid Development of COVID-19 Diagnostic Tests
- Chapter 5 Coordination of Resources for the Manufacturing and Deployment of COVID-19 Diagnostic Assays
- Chapter 6 Quality and Risk Management Processes for Diagnostic Assays during an Emergency Pandemic Response
- Chapter 7 Development of Assays to Diagnose COVID-19
- Chapter 8 Laboratory Verification and Clinical Validation of COVID-19 Diagnostic Assays
- Chapter 9 Importance of Timely Sequencing, Tracking, and Surveillance of Emergent Variants
- Chapter 10 The RADx® Regulatory Core and Its Role in COVID-19 Emergency Use Authorizations
- Chapter 11 Commercialization and Market Assessment of COVID-19 Assays
- Chapter 12 Testing Strategies to Mitigate COVID-19 Disease Spread
- Chapter 13 A Pandemic Not Just of Infection but of Inequality: The Social Impact of COVID-19
- Chapter 14 Summary and Path Forward for Future Pandemics
- Index
- References
Summary
This chapter explores the quality management system re-prioritization efforts employed by Rapid Acceleration of Diagnostics (RADx®)-supplied content experts to support rapid product development and commercialization of COVID-19 diagnostic tests. The chapter also explores the interplay between quality, development, manufacturing, and risk management. While the chapter is applicable to companies of all sizes, particular emphasis is placed on describing a roadmap for small businesses and start-ups without the mature quality management systems and teams in place that a larger company may have.
Keywords
- Type
- Chapter
- Information
- Accelerating Diagnostics in a Time of CrisisThe Response to COVID-19 and a Roadmap for Future Pandemics, pp. 103 - 124Publisher: Cambridge University PressPrint publication year: 2024
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