"The FDA Medical Device Pre-Submission Program and FDA Meetings"
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on The FDA Medical Device Pre-Submission Program and FDA Meetings Date: Tuesday, December 3, 2013 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Location: Online Register Now Instructor: Albert A. Ghignone 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. Areas covered in the session: l Understanding the FDA Medical Device Pre-Submission program l How to prepare an FDA Medical Device Pre-Submission Package l Types of FDA Pre-Submission meetings l How to Request, Prepare For and Conduct FDA Meetings Who Will Benefit: About Speaker Albert A. Ghignone l Regulatory Affairs Professionals Chief Executive Officer and President, AAG l Quality Professionals Incorporated l Clinical Professional Albert is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related l Manufacturing Professionals matters in regulatory affairs, quality assurance and l Research Professionals clinical affairs. He has expertise in dealing with all l Other professional that require an aspects of the FDA approval process for drugs, understanding of the FDA Medical biologics, medical devices and generic drugs. He has worked in every major segment of the industry- Device Pre-Submission program research, quality assurance, ...more Click here to register for this webinar Suggest a Topic More Webinars GlobalCompliancePanel www.globalcompliancepanel.com 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe