The 510(k) Program: Substantial Equivalence In Premarket Notifications

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Description:

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.

Areas to be Covered:

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

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 510(k) program for determining substantial equivalence

Albert A. Ghignone

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.

This product is currently out of stock and unavailable.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance