Extension and understanding of the Software & Systems Risk Management Plan with ISO 14971 (This presentation wi)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Sep 11, 2008
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This webinar will provide a pragmatic approach to all regulated companies that need to validate their systems, including companies in the combination devices world which has aspects of drugs and devices in embedded devices and which has aspects of hardware, software, and reagents in their products.

Risk Management plans are generally written in a unilateral understanding. When one focuses on drug and device as a combination, risk management plans almost always forget to include the flexibility provided by the system environment in risk mitigation. For instance, from the software perspective, procedural risk mitigations can be ongoing code reviews. From the hardware perspective, the device could be fail-safe and have a delayed start to enable the initial protocols to be exercised. The drug environment calls for a more rigorous risk management plan which can be easily adapted in the device world. Nevertheless, it is essential to consider the device world failure modes in a pragmatic fashion to determine how the risks are mitigated.

This presentation will provide an understanding of the devices and drug risk management plan and its application in risk mitigation. Appropriate examples will be provided that will suggest how risks can be mitigated and what practical approaches need to be considered to assure integrity in the risk management plan.