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Final Rules of Unique Device Identification

Online

Wednesday, February 14, 2018

 

 

Overview: This webinar will address the four key steps to compliance by device manufacturers. Also covered will be the Final Rule's provisions to address existing FG inventory, not properly labeled. Why should you Attend: It will also review the implementation schedule which is required of medical device companies selling products in the U.S. This is a major change for medical device manufacturers, with far-reaching effects in regulatory compliance, as envisioned by the FDA. Areas Covered in the Session: Learn the basic requirements of UDI Labeling and its Database UDI / GUDID Implementation Schedules Required steps for UDI / GUDID compliance by the Medical Device Company Future Requirements Who Will Benefit: Process Validations CGMP Responsibilities CROs and Clinicals Personnel Medical Personnel Other Healthcare Professionals Staff and Office Personnel Speaker Profile: John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. Event Fee: One Dial-in One Attendee Price: US$150.00 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com

 

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