Online Safety Community

FDA New Draft Guidance on (Software) and Device Changes 510k

Event Details

FDA New Draft Guidance on (Software) and Device Changes 510k

Time: October 12, 2018 from 9am to 12pm
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: https://www.compliance4all.co…
Phone: Event Manager
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Aug 8

Export to Outlook or iCal (.ics)

Event Description

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: support@compliance4All.com

Comment Wall

Comment

RSVP for FDA New Draft Guidance on (Software) and Device Changes 510k to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
5 hours ago
Training Doyens posted events
9 hours ago
Alexandr Grigoryev posted a blog post

How to ensure that PPE will protect you

If you look at the hazard control hierarchy, wearing personal protective equipment holds as the last hazard control. It is the last protection for a worker against particular hazard. However, there is no guarantee that the worker will remain safe from health risk, injury or even death when he or she already wears personal protective equipment.If you think that new and expensive personal protective equipments will provide full protection, then you are absolutely wrong. They could not guarantee…See More
17 hours ago
Profile IconJohn Liriotakis, Dayna Stewart, Gautam Chattopadhyay and 1 more joined Online Safety Community
yesterday

Forum

Biggest Challenge? 5 Replies

As a distributor of safety supplies, as a webmaster who is trying to sell safety supplies online, one of my main goals is to try to provide value above and beyond just selling supplies and product.So…Continue

Started by Safetyguy08. Last reply by Jen McDade 9 hours ago.

[General Industry] What is your workplace's policy on headphones? Working on one currently.

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue

Tags: general, industry, distraction, music, phone

Started by Kyle C. Johnson on Friday.

AI Machine Learning In Businesses How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?

How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?However you define уоur оwn ѕmаll business, it tоо can tаkе advantage оf thе AI/ …Continue

Tags: elite, crest, technologies, intelligence, Artificial

Started by emmablisa Dec 10.

Distracted Driving 1 Reply

****WARNING**** Despite the fact that this is a life event portrayed by actors, it's graphic. This video should be part of…Continue

Tags: texting, fatality, safety, car, driving

Started by Wendy. Last reply by Jen McDade Dec 5.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service