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Webinar On DeNovo Classification Process

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Description: This webinar provides information on FDA’s DeNovo classification process. The webinar explains how a device classified as a Class III device but has the risk level of a Class I or II device may be downclassified to its correct risk classification. The webinar will cover when the DeNovo process may be used, information contained in a DeNovo request, the 2 DeNovo pathways and FDA review process for DeNovo.
This is a must attend session for those personnel that require an understanding of the FDA’s DeNovo Classification process.
Areas Covered in the Session :
FDA DeNovo Classification Process
Request for DeNovo application
2 DeNovo Pathways
FDA DeNovo Review Process
Interactive Q&A Session
Who Will Benefit:
Regulatory Affairs Personnel
Quality Personnel
Clinical Personnel
Research Personnel
Laboratory Personnel
Manufacturing Personnel
Legal Personnel
Clinical Research Associates
Personnel who require a general understanding of the FDA’s DeNovo Classification Process
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candle brook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support: 416-915-4458
Email: support@compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1403
URL: https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1403
Date: Monday, November 24, 2014
Time: 6:00pm-8:00pm UTC
Duration: 2 hours
Access: Public
Category: Technology*, Webinar*, Health*
Created by: Public Access
Updated: Friday, October 31, 2014 12:37pm UTC
Cost ($): $249
Call In Number: 4169154458
Contact Email: uttam@compliancetrainings.com
Contact Person: Uttam Mandal
Contact Phone: 416915445
Comments: None


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