Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series
The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is the time to get up to date on managing risk to safely produce healthcare products!
In order to help you, we have gathered chapters from our most successful risk-based texts. These convenient, electronic texts define risk, discuss hazards and risks, provide tools to help you evaluate risk, and develop effective strategies for dealing with risk.
Written by subject matter experts, each text contains practical applications, an extensive list of international regulations for reference, and suggested PDA Technical Reports and books for further guidance.
Risk Management Library Volume 1: Lifecycle Risk Management
This publication is taken from the book: Lifecycle Risk Management for Healthcare Products: From Research Through Disposal published in 2016.
Written by experienced authors, this Volume offers insight into the risk management processes, management considerations, and strategies in product development, implementation of risk management for non-product software, and the future of risk management.
Available to download. Prior to purchase please view the download instructions and Terms of Usage
Format: PDF (1 file 3.53 MB)
Table of Contents:
Click here to download >>>Detailed Table of Contents
- Risk Management Processes by Edwin Bills. (Chapter excerpted from Lifecycle Risk Management for Healthcare Products, Chapter 3 published 2016)
- Risk Management Considerations and Strategies in Product Development by Susan W. Neadle. (Chapter excerpted from Lifecycle Risk Management for Healthcare Products, Chapter 8 published 2016)
- Why Implement Risk Management for Non-Product Software? by Tina Adamowski Krenc. (Chapter excerpted from Lifecycle Risk Management for Healthcare Products, Chapter 10 published 2016)
- The Future of Risk Management by Stan Mastrangelo. (Chapter excerpted from Lifecycle Risk Management for Healthcare Products, Chapter 12 published 2016)
Current Regulations, Guidances, Technical Reports and Texts Useful for Further Reference.
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.