Event:
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Best Practices With Submissions Under Medical Device User
Fee Act (MDUFA) III
- Hosted By:
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ComplianceOnline
- Start:
- Friday - Mar 28, 2014 10:00 AM
- End Time:
- Friday - Mar 28, 2014 11:30 AM
- Location:
- Online
- This webinar will present the results of the MDUFA III and will describe how your company will need to do business with the FDA in the next five years. It will describe how the FDA will use the User Fees to make changes within the agency and the expectations that the FDA will have of your company, as a result of those changes, to help your company prepare both strategically and tactically for regulatory interactions in the next five years.
Why Should You Attend:
Change is inevitable; Suffering is optional!!! This is the best way to describe the Medical Device User Fee Act III that, among other things, changes the way that the FDA accepts submissions for Medical Devices. This will cause significant changes in how Medical Device Companies need to handle 510(k) and PMA submissions between the years 2012-2017.
This 90-minute webinar will include a review of the changes the FDA is making in accepting Medical Device Submissions and will propose solutions to some of the problems that will result from those changes. The goal of the webinar is to reduce or eliminate suffering from these changes, by discussing the strategies required to move forward with minimal disruption to your business. The new guidances that have resulted from “Refusal-to-Accept” and Electronic Submissions of Medical Device applications will also be presented.
Who will Benefit:
-Medical Device Regulatory Affairs
-Medical Device Quality Assurance
-Clinical Research
-Clinical Trial Data Management
-Data Monitoring
-Institutional Review Board
-Clinical Trial Physicians
-Principal Investigators
-Clinical Investigators
-Institutional Review Boards
-Data Monitoring Committees
-Medical Device CROs
Instructor Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.
Ms Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.
- Website:
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Visit the website for detail info