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GlobalCompliancePanel, Online Training, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
2013-12-03
Overview: The FDA Medical Device Pre-Submission Program is intended for companies to obtain FDA feedback on questions for future applications prior to their submission.
The submissions include Investigational Device Exemptions (IDE), Premarket Approval Application (PMA), Humanitarian Device Exemption (HDE) and 510(k) applications. This FDA Medical Device Pre-Submission Program also allows FDA to provide advice to applicants who are developing Medical Device clinical protocols, nonclinical protocols and other studies during the development of their Medical Device. The FDA Medical Device Pre-Submission Program can be used to work with FDA from Medical Device concept to market. Also addressed will be how to request, prepare for and conduct FDA meetings.
Why Should You Attend: This web presentation is for those professional that require FDA feedback on new Medical Devices in the developmental stage. The FDA Medical Device Pre-Submission Program is intended to solicit FDA feedback prior to an FDA submission being made. The FDA Medical Device Pre-Submission Program also allows the user to obtain FDA feedback on clinical protocols, nonclinical studies and other studies during the development of a Medical Device.
Areas Covered in the Session:Understanding the FDA Medical Device Pre-Submission program
How to prepare an FDA Medical Device Pre-Submission Package
Types of FDA Pre-Submission meetings
How to Request, Prepare For and Conduct FDA Meetings
Who Will Benefit:
Regulatory Affairs Professionals
Quality Professionals
Clinical Professional
Manufacturing Professionals
Research Professionals
Other professional that require an understanding of the FDA Medical Device Pre-Submission program
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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2013-12-03
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Registration:
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Contact Details: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Register Now
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E-mail:
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globalcompliancepanel@gmail.com
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