Best Practices With Submissions Under Medical Device User Fee Act (MDUFA) III
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.
Areas Covered in the Webinar:
- How the FDA got from MDUFA I to MDUFA III
- New Law: FDA Safety & Innovation Act (FDASIA)
- Process & Policy Improvements
- Updated Quantitative Goals
- MDUFA III Review Times
- Infrastructure Improvements
- Other Provisions
- Key Highlights
- Elimination of Exemptions for Registration Fees
- Electronic Copy Provision
- Implementation of MDUFA III
- Hiring
- Required MIII Guidance
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
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.
More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry.
