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FDA's Regulation of Implantable and Wearable Sensors

ComplianceOnline

Thursday, October 6, 2016 at 8:30 AM - Friday, October 7, 2016 at 4:30 PM (EDT)

FDA's Regulation of Implantable and Wearable Sensors

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (With 3 Nights Stay) Oct 6, 2016 $2,399.00 $0.00
Seminar One Registration Oct 6, 2016 $1,999.00 $0.00

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Course Description:

Sensors have begun to revolutionize human health due to their ability to provide real time health monitoring under a diverse set of conditions. For example, sensors can provide real time information such as heart rate, blood pressure, biomolecular concentrations, glucose levels, motion and exercise data, neural activity, and so much more. While wearable sensors have seen an explosion in use, the reliability of such data collected has been questioned. Moreover, very little has advanced in terms of implantable sensors, yet implantable sensor can provide much more in depth and variety of health data compared to wearable sensors. Implantable sensors also have the capability to reverse adverse health affects, whereas wearable sensors do not.

This tutorial will provide an historical context for the use of wearable as well as implantable sensors in medicine, where the field has been and where it is going. It will also provide a few examples of FDA approved sensors in medicine and what is needed for the field to progress. Currently, there is an ongoing debate in industry on how such sensors should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as medical devices, drugs or simply biologics.

Learning Objectives:

Upon completing this course participants should have an understanding of:

  • Fundamentals of sensors
    • What is all the excitement about
    • How to build sensors
    • Wearable versus implantable sensors
    • Incorporating cells and/or biological materials into sensors
    • Avoiding immune system clearance of sensors
    • Biological reactions to sensors
  • FDA regulatory approvals for sensors
    • Currently approved sensors in medicine
    • FDA guidance documents for sensors
    • Global approval of sensors

 

Who will Benefit:

This course is designed for professionals in wearable and implantable sensors such as for researchers, business personnel, start-up companies, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers

 

For Registration -  http://www.complianceonline.com/fda-regulation-implantable-wearable-sensors-seminar-training-80416SEM-prdsm?channel=eventbrite         

 

Note: Use coupon code < NB5SQH8N > and get 10% off on registration.

Have questions about FDA's Regulation of Implantable and Wearable Sensors? Contact ComplianceOnline

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When & Where


Boston

Boston, MA

Thursday, October 6, 2016 at 8:30 AM - Friday, October 7, 2016 at 4:30 PM (EDT)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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FDA's Regulation of Implantable and Wearable Sensors
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