Risk Management Basics
Protecting Profits and Product Safety in Medical Product Industries Through Risk-Based Decision-Making in Change Control, Deviation Investigations, and CAPA Programs
by Carol DeSain and Charmaine Sutton
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Risk Management Articles
These articles have been written to share our experience with implementation of risk management systems in Pharma/Biotech industries. They provide detailed examples of how to create and/or perform the various risk assessment activities in a Pharma/Biotech environment. They are also written to provoke questions, points of clarification and frustrations from the industry, as this series of articles precedes a Pharma/Biotech version of our Risk Management Basics book. As a result, we ask for your comments at carol@thetamarackgroup.net. We intend to expand the examples as we have time. Let us know what would be most useful to you.
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Risk Management Basics: Product Risk Profile Documents
Effective Risk Communication between Product Development and Operations
by Carol DeSain
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Risk Management Basics: Product Requirements Documents
by Carol DeSain
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Risk Based Quality Management Systems
by Carol DeSain
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Risk Management Basics: Process Risk Profile Documents
Effective Risk Communication between Product Development and Operations
by Carol DeSain
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Disclaimer
The books, book chapters and documents provided by Tamarack Associates, LLC on this site are provided "as is" without any warranties of any kind including warranties of merchantability, fitness for a particular purpose or non-infringement of intellectual property. The materials are provided for your professional use. We expect that you will make copies for your own use but we also expect that you will refrain from and not profit from mass reproduction of this information.
Furthermore, Tamarack Associates, LLC does not warrant the accuracy or completeness of the materials at this site, and may make changes to the materials and prices at any time without notice. The information provided in these documents is of a general nature. The examples provided in the books and the example documents are simply examples for you to use as a starting template; they are not intended to address the specific circumstances of any particular organization or individual. Therefore, you should always consult a suitably qualified professional before applying the information in these documents to your specific situation.
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