Your event should be here ! To publish, manage, promote... To learn or to be formed ... Online registrations

Site language : English - Français
Ref : 27900
Event :FDA New Draft Guidance on (Software) and Device Changes 510k

Date :Friday October 12th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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

Further information

To access the information you need to be connected. Creating an account is easy and free!

Log to your account
Register on Doctorama

Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

Other events from Compliance4All

Presentation sheet from Compliance4All

Details

FDA New Draft Guidance on (Software) and Device Changes 510k Medicine - Bio-Technologies - Management - National Health - Public Health - Toxicology
medical conference, 2018 medical trainings, 2018 online webinars, 2018 conferences
Professionals, Compliance Managers and Auditors Lab Managers and Analysts Automation Analysts Computer System Validation Specialists
100 1 --
English

Other

For more information on FDA New Draft Guidance on (Software) and Device Changes 510k, plsase contactr Compliance4All

To display announcer website, you must be logged

Log to my account
Register on Doctorama


Recommend this event