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Final Rules of Unique Device Identification

Event Details

Final Rules of Unique Device Identification

Time: February 14, 2018 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: Event Manager
Event Type: online
Organized By: Adam Fleming
Latest Activity: Dec 5, 2017

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Event Description

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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