Webinar On Annual Reports for Approved PMAs
November 7, 2014 - Mississauga ON CACompliance Trainings
suzzane.d@compliancetrainings.com
Phone:4169154458
This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the PMA annual report. Also addressed are the steps FDA staff generally takes when reviewing annual reports and the actions FDA may recommend after the annual report review. Also covered in this webinar are other reports – post-approval study reports. A must attend webinar for those personnel that require an understanding of the FDA’s requirements for PMA annual reports. Areas Covered in the Session : Contents of a PMA Annual Report Detail Required in an PMA Annual Report FDA Review of PMA Annual Reports Actions FDA May Recommend After PMA Annual Report Review Post-Approval Study Reports 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 Requirements for PMA Annual Reports 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