Biocompatibility Risk Management for Clinical and Regulatory Professionals

Biocompatibility Risk Issues
The biocompatibility testing decisions you make will affect the ease of your submission approval process and help protect you from the device recalls your competitors may be undergoing. Following the  risk management and biocompatibility guidance contained in ISO 14971 and ISO 10993 may not be enough, you need to think proactively to what questions or issues may lie ahead.

Minimizing Risk
In this e-conference a teamwork approach -- from the individual developer to authoritative third-party review -- will be emphasized to help you to "do the right test right" and enable you to defend your product safety decisions. Current FDA Class I recalls will be used as examples.

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Limitations of Testing
Biocompatibility testing will be explained from an historical perspective. However, since it is not a perfect science, discussion of a historical clinical failure will be used as an example of its limitations.

Helping Your Reviewer
Knowing that your submission reviewer is quite likely new to their job and is constantly faced with career-ending decisions (i.e., incorrectly approving a device that should not have been approved, or not approving a device that should have been approved), we will help you gain their trust and respect in order to minimize post-submission questions and issues.

Audience Suitability
[x] Regulatory professionals-craft better submissions.
[x] Clinical research professionals-speak knowledgeably to investigators and IRB.
[x] Marketing professionals-to help you better compete on safety issues.
[x] Managers and decision makers-spend your money more wisely.
[x] Executives for start-up companies-understand what's needed.

You will receive:
[x] PowerPoint Slides.
[x] An expert speaker.
[x] Examples you can use.
[x] Insight into the biocompatibility process.
[x] A chance for Q&A.
[x] CEUs & Certificate.

Presenter:
Dr. Daniel McLain, MS/PhD, of Walker Downey and Associates, has more than 20 years experience with medical devices, biologics, and pharmaceuticals. His expertise is in completing the necessary preclinical strategies for successful 510K, BLA or IND submissions, including contemporary risk assessments and expert opinions.

Dr. McLain is an internationally recognized toxicologist in the medical device industry and currently serves as the Convener for ISO10993: Biological evaluation of medical devices – Part 11: Systemic toxicity evaluation. He has had extensive interaction with global regulatory bodies as it pertains to product safety submissions and is held in high regard for his development strategies and commitment to product safety.

The purchase is $423 for OnDemand access and $473 for the CD. Event materials are available by download for OnDemand or are on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.