Overview: This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. Overall Residual Risk Evaluation requires a cross-functional team to perform the evaluation, which will be an important part of this presentation.
Why you should attend: One of the most important Risk Management activities is the Overall Residual Risk Evaluation which occurs at the end of the development cycle to assure the product risk meets the risk acceptability criteria prior to issuing the Risk Management Report and release of the product. Companies have not had methods in place to perform this activity, and although some information appears in ISO 14971, there is not sufficient guidance on how to perform Overall Residual Risk Evaluation.
Areas Covered in the Session:
* Choosing the Evaluation Team
* Determining the Evaluation Process
* What documents should be part of the review?
* Using the Risk Chart in the review
* How to compare to the Risk Acceptability Criteria
* Documenting the results of the Evaluation
Who will benefit:
* Risk Managers
* Project Managers
* Quality Engineers
* Regulatory Managers
* Clinical Managers
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
Why you should attend: One of the most important Risk Management activities is the Overall Residual Risk Evaluation which occurs at the end of the development cycle to assure the product risk meets the risk acceptability criteria prior to issuing the Risk Management Report and release of the product. Companies have not had methods in place to perform this activity, and although some information appears in ISO 14971, there is not sufficient guidance on how to perform Overall Residual Risk Evaluation.
Areas Covered in the Session:
* Choosing the Evaluation Team
* Determining the Evaluation Process
* What documents should be part of the review?
* Using the Risk Chart in the review
* How to compare to the Risk Acceptability Criteria
* Documenting the results of the Evaluation
Who will benefit:
* Risk Managers
* Project Managers
* Quality Engineers
* Regulatory Managers
* Clinical Managers
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
