Webinar On DeNovo Classification Process
November 24, 2014 - Mississauga ON CACompliance Trainings
suzzane.d@compliancetrainings.com
Phone:4169154458
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