FDA New Draft Guidance on (Software) and Device Changes 510k

Website https://www.compliance4all.com/control/w_product/~product_id=502118LIVE?channel=ourglocal_Oct_2018_S | Edit Freely

Category Clinical Data Managers and Scientists, Analytical Chemists, Quality Managers

Deadline: October 11, 2018 | Date: October 12, 2018

Venue/Country: Online, U.S.A

Updated: 2018-08-07 14:24:58 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com