Webinar On Medical Device User Fee Act (MDUFA) III

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Webinar
On Medical Device User Fee Act (MDUFA) III
Product Id
MD1056
Category
Medical Devices
Scheduled On
Friday, June 20, 2014 at 1300 Hrs
Duration
90 Minutes
Speaker
Angela Bazigos
To Know more visit https//compliancetrainings.co
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Webinar Description

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. The new guidance that have
resulted from Refusal-to-Accept and Electronic
Submissions of Medical Device applications will
also be presented. Device user fees were first
established by Congress in 2002. Medical device
companies pay fees to FDA when they register
their establishment and list their devices with
the agency, whenever they submit an application
or a notification to market a new medical device
in the U.S. and for certain other types of
submissions. As part of receiving such fees, the
FDA makes commitments to the industry with
regards to certain performance goals with regards
to review and approval processes and
timelines. The Medical Device User Fee
Amendments of 2012, or MDUFA III took effect on
October 1, 2012 and will sunset in five years on
October 1, 2017. During that time, the processes
for interacting with the FDA will be updated,
impacting the way a medical device manufacturer
does business with the FDA. 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 webinar will include 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 / eliminate suffering from
these changes, by discussing the strategies
required to move forward with minimal disruption
to the business.

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Areas Covered in the Session
Applicable Statutes and Regulations Definitions FD
A Manuals FDA Inspection Scope and
Depth Inspection Types and Categories Inspection
Classification Inspection Process Hosting an FDA
Inspection Act with Awareness and
Familiarity Common Questions and Responding to
Questions
Who Will Benefit
CEOs VPs Compliance Officers Attorneys Regulatory
Affairs Clinical Affairs Quality
Assurance Research Development
Teams Consultants Contractors/Subcontractors Anyon
e Interested in the FDA inspection Process
Speaker Profile

Angela Bazigos is the CEO of Touchstone
Technologies Silicon Valley, Inc. Your Passport
to Compliance. She has 30 years of experience in
the Life sciences 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.
To register this webinar visit
https//compliancetrainings.com/siteengine/Login.a
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