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UPCOMING WEBINARS

MEDICAL DEVICE

FDA LABELING REQUIREMENTS FOR MEDICAL DEVICES

Friday, 2nd December, 2022
Time : 01:00 PM EST | 11:00 AM PST


REGULATORY/QUALITY

THE FDA CGMP AND DATA INTEGRITY IN PHARMACEUTICA...

Friday, 9th December, 2022
Time : 01:00 PM EST | 10:30 AM PST




LIVE WEBINAR


FDA LABELING REQUIREMENTS FOR MEDICAL DEVICES

INSERT_INVITATION FRIDAY, 2ND DECEMBER, 2022

ACCESS_TIME 01:00 PM EST | 11:00 AM PST

TIMELAPSE 60 MINS WITH 10-15 MINS OF Q AND A

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SPEAKER/PRESENTER

Sheila J. Ramerman, RAC

Founder

SJR Associates

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SHORT ABSTRACT

FDA regulates all labeling for medical devices. This webcast outlines the
general labeling requirements for all medical devices – including
over-the-counter devices, IVD devices, investigational devices, and
electronic/radiation-emitting devices. The webinar explains concepts such as
“label” vs. “labeling”, “adequate directions for use”, “claims”, “intended use”,
“indications for use”, and “off-label use”. It includes short discussions of
electronic labeling UDI (Unique Device Identifier) requirements,
advertising/promotion of medical devices using product claims and promotional
claims, and off-label use of devices.

Areas Covered in the Webinar:



 * FDA requirements
 * UDI, Standardized Date Format, GUDID
 * Claims – product claims and promotional claims
 * Intended Use and Indications for Use
 * Off-label use – What is it? When is it OK to distribute information on
   off-label use?



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APPLY FOR THIS WEBINAR

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WHO SHOULD ATTEND

Anyone who is involved in labeling activities, especially sales & marketing, and
QA/RA. Anyone interested in an overview of the FDA’s labeling requirements.


SERVICES

In House Trainings

Online Trainings

Consulting


WEBINARS

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Recorded Webinar


SEMINARS

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Recorded Seminar


BIOPRACTICE


CALL US : 1-646-216-8860



CONTENT DISCLAIMER

Contents in our website are from external websites. Links to and content from
external website are provided for the convenience of users. Biopractice.com
takes no responsibility for the content of such links and websites.

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