161 Mission Falls Lane, Suite 216,, Mission Falls Ln

Fremont,

California,

USA,

ZIP: 94539

Phone: 8004479407

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: [email protected]