Webinar Search Results : 3 Upcoming webinars found.
John E Lincoln Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
View Details
John E Lincoln Wednesday, March 20, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John E Lincoln
Device Changes, FDA Changes, and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
View Details
John E Lincoln Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
View Details
Newsletter

Main Links

Payment Methods

Contact Us

NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

Information

  Refund Policy
  +1-800-447-9407
  Fax: 302 288 6884
  support@compliance4All.com


Copyright © 2019 compliance4All. All rights reserved.

USAEpay