"Meet the U.S. FDA's Tougher Requirements for the 510(k) - Webinar By GlobalCompliancePanel"
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Meet the U.S. FDA's Tougher Requirements for the 510(k) Date: Wednesday, March 20, 2013 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Location: Online Instructor: John E Lincoln Course "Meet the U.S. FDA's Tougher Requirements for the 510 (k)" has been pre-approved by RAPS as eligible for up to 1.5 credits Register Now towards a participant's RAC recertification upon full completion. Overview: This webinar will evaluate medical device review routes under Exempt, 510(k) / PMN, and PMA, as both a process and as documentation / submissions. The 510(k) process and submission documentation, the role of the IDE, and the PMA process and submission documentation will be evaluated and discussed. The 21 elements of the 510(k). What is an IDE, and what is its format and role. The tailored FDA approach to the PMA. The broad range of U.S. FDA / regulatory issues to be considered by a company approaching the introduction of a new or changed device will be discussed, whether domestically manufactured or imported. Areas covered in the session: l Tougher Expectations / Requirements l The 510(k) - Pre-market 'notification' and FDA Device Clearance l Predicates and Substantial Equivalence l Intended Use / Indications for Use l The IDE - Investigational Device Exemption; IRB's; Disclosures l Clinical - the 'basics' l The PMA - Pre-market Approval l Resolving a "Wrong" Decision Who Will Benefit: About Speaker John E Lincoln l Senior management in Consultant, Medical device and Devices and Combo Regulatory affairs, Products John E. Lincoln is a medical device l QA and regulatory affairs consultant. He l RA has helped companies to implement or modify their GMP systems and l R&D procedures, product risk l Engineering management, U.S. FDA responses. In l Production addition, he has successfully designed, written and run all types of l Operations process, equipment and software l Consultants qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer- reviewed technical articles, and workshops, world wide. ...more Click here to register for this webinar Suggest a Topic More Webinars GlobalCompliancePanel www.globalcompliancepanel.com 43337 Livermore Common, 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