FDA New Draft Guidance on (Software) and Device Changes 510k

Overview:
A 510(k) is a premarket submission made to FDA to demonstrate that the

device to be marketed is at least as safe and effective, that is,

substantially equivalent, to a legally marketed device (21 CFR 807.92(a)

(3)) that is not subject to PMA.

Why should you Attend:
This includes any major change or modification to the intended use of the

device that could have an impact on patient safety and effectiveness. After

attending this webinar, you will be able to better navigate the processes

required to determine how to manage software and device changes in an

FDA-compliant manner.

Areas Covered in the Session:
Medical Device changes
Software Application changes for software used in conjunction with

medical devices
FDA Guidance Documents
FDA Enforcement
New 510(k) submission
Substantial Equivalence

Who Will Benefit:
Information Technology (IT) Analysts
IT Developers
IT Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Quality Managers, Chemists and Microbiologists
Compliance Managers and Auditors
Lab Managers and Analysts

Speaker Profile:
Carolyn (McKillop) Troiano has more than 35 years of experience in the

tobacco, pharmaceutical, medical device and other FDA-regulated

industries. She has worked directly, or on a consulting basis, for many of

the larger pharmaceutical and tobacco companies in the US and Europe,

developing and executing compliance strategies and programs. Carolyn is

currently active in the Association of Information Technology

Professionals (AITP), and Project Management Institute (PMI) chapters in

the Richmond, VA area.

Event Fee: One Dial-in One Attendee Price: US $290.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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WHEN AND WHERE

12 October 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Health