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Webinar Description:

Areas Covered in the Session :
The 510(k) Program: Substantial Equivalence In Premarket Notifications
Product Id MD1229
Category Medical Devices
Scheduled On Wednesday, September 24, 2014 at 13:00 Hrs
Duration 120 Minutes
Speaker Albert A. Ghignone


510(k) Regulatory Framework
510(k) Policies
510(k) Practices
510(k) Critical Decision Points for Substantial Equivalence
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.

Who will benefit:
Regulatory Affairs Personnel
Quality Personnel
Clinical Personnel


To register visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1229



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

Speaker Profile:
Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus
has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has
expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical
devices and generic drugs. He has worked in every major segment of the industry-research,
quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for
regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA
training. He also has expertise in the assessment of product and facilities for due diligence
relative to FDA requirements.

He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA
and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In
addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and
Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical
Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs
Professionals Society which elected him the 1984 Professional of the Year. He has served the
society as Vice President, President and Chairman of the Board of Directors.

In recent years he has filed numerous FDA drug, biologic and medical device submissions for
product approval. In addition he has been involved in two of the largest clinical trials conducted,
the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.