Sharing Knowledge, Solving Problems: Risk Analysis, Benefit-Risk, & More
In Exeed’s Latest Webinar, Dr. Naveen Agarwal Discusses Risk Management, Benefit-Risk Assessments, and Other Submitted Questions About ISO 14971
We’re happy to share the recording of the most recent session of our webinar series, Sharing Knowledge, Solving Problems. During this interactive Q&A session, Dr. Naveen Agarwal fielded questions surrounding ISO 14971 with topics including risk analysis, ICH Q9, FMEA, PHA, and more. We’re thrilled to see the community coming together to discuss questions and obstacles in the risk management industry. This dialogue is key to developing understanding and finding solutions to future challenges.
Watch the Webinar
Below, you can find a recording of the webinar session hosted October 27 as well as timestamps for the questions asked.
Timestamps for Questions Asked:
01:18 - How do you communicate ROI on risk management activities to your Executive leadership?
04:16 - How to do risk analysis?
06:48 - What is the difference between FMEA and PHA?
12:24 - When is it possible to show a reduction in the severity of harm through risk control measures?
21:43 - Where and how to use a risk assessment during design and development?
25:40 - How does Human Factor Engineering/Usability relate to risk management?
28:28 - How do you integrate ISO 14971 with ICH Q9 for Combination Products?
33:20 - Can you give examples of risk management questions asked during audits/inspections?
40:26 - What are some of the best practices in risk management? How to proactively monitor post-market surveillance activities? How to do a benefit-risk assessment?
42:53 - How to estimate the probability of harm for a novel product during development?
We look forward to hosting further discussions and to continuing to share out knowledge. To register for future webinars, click here.