Webinar On The 510(k) Program: Substantial Equivalence In Premarket Notifications
August 27, 2014 - Mississauga ON CACompliance Trainings
suzzane.d@compliancetrainings.com
Phone:4169154458
This guidance was released on July 28, 2014. FDA developed this document to provide guidance about current review practices for premarket notifications (510(k)) submissions. FDA's intent is to identify, explain and clarify each of the critical decision points in the decision making process FDA uses to determine substantial equivalence. The intent of this document is to enhance the predictability, consistency and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies and practices underlying FDA's 510(k) review process. This webinar is a must for those personnel that require an understanding of the FDA's 510(k) substantial equivalence determinations. Areas Covered in the Session : 510(k) Regulatory Framework 510(k) Policies 510(k) Practices 510(k) Critical Decision Points for Substantial Equivalence 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 510(k) program for determining substantial equivalence 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