This book provides current information on the risk management process as it applies to health and safety of health products, drugs and biologics, medical devices and products that are a combination of two or more of these. The application of the processes will help manufacturers of these products to create and maintain products that are at an acceptable level of safety for society through the product lifecycle.
This book has been divided into two parts, part one covers healthcare risk management processes and frameworks and part two covers special topics.
In the first part, the editors provide a historical perspective of the risk management framework as well as management and its responsibilities for implementation of risk management in health product companies. You will also find an overview of combination products, use of risk traceability, criteria for risk acceptability and production and post-product risk management in this section.
In the second part, specific applications of health product risk management are examined, including clinical trials, quality system software and in vitro diagnostic devices.
Table of Contents:
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Part 1: Healthcare Risk Management Processes and Frameworks
- History of Risk Management by Stan Mastrangelo
- Management Responsibility for Risk Management and Product Safety by Alfred M. Dolan P.E. and Edwin Bills
- Risk Management Processes by Edwin Bills
- Risk Management for Combination Products by Edwin Bills
- Risk Management and the Risk Traceability Summary by Edwin Bills
- Criteria for Risk Acceptability by Stan Mastrangelo
- Production and Post-Production Risk Management by Thomas Morrissey M.D.
Part 2: Special Topics
- Risk Management Considerations and Strategies in Product Development by Susan W. Neadle
- In Vitro Diagnostics Risk Management by Tina Adamowski Krenc
- Why Implement Risk Management for Non-Product Software? by Tina Adamowski Krenc
- Transition to Enterprise Risk Management by Stan Mastrangelo
- The Future of Risk Management by Stan Mastrangelo
About the Editors
Edwin Bills, during his career, Mr. Bills has held a number of quality and regulatory affairs positions including a recent period as Corporate Director of Risk Management. He has over 30 years' experience in the field of quality and regulatory affairs. Currently he consults and provides training to a wide variety of clients in pharmaceutical, medical device, and combination products quality, regulatory, and risk management. Mr. Bills served in international standards work, participating in the development IEC 60601-1 electrical medical device standard, AAMI QM/WG01 for the medical devices quality system standard, ISO 13485, and the international committee, ISO TC 210/JWG1 on medical device risk management.
Stan Mastrangelo retired from Abbott Labs after 24 years in Quality Assurance. Stan worked in Medical Devices, Pharmaceuticals, and Foods. He participated in the development of several International Standards related to Product Health and Safety Risk Management of Medical Devices and Pharmaceuticals. Stan also was a member of the original committee that created ISO 31000 for Enterprise Risk Management. Stan has been teaching Risk Management since 2000 and has industry since 2006. Stan has taught and spoken in many different forums such as ASQ, AAMI, AdvaMed, Barnett, Virginia Tech, USC, Med Tech Intelligence, and many others.