Loading Purplepass...
Computer System Validation 2018 Fundamentals
Presented By Netzealous LLC DBA - Compliance4All
Tuesday, October 23rd at 10:00am PST
Online sale ends: 10/23/18 at 9:00am PST
Online
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539
-= series =-
Buy Tickets
|
Talent
Description
Overview: FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than testing. It is testing plus design control and configuration management. Why should you Attend: Validation of computer system software is completely different than validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission. Areas Covered in the Session: Validation strategy Requirements documentation Complexity and risk analysis Creating a detailed test plan based on risk Supplier qualification IQ, OQ and PQ Who Will Benefit: Computer System Developers Systems Development Engineers QA/ QC Lab Managers and Analysts Production Managers Engineering Managers Speaker Profile: Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network. Event Fee: One Dial-in One Attendee Price: US$150.00 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com Additional Information
https://www.compliance4all.com/control/w_product/~product_id=502115LIVE?channel=purplepass_Oct_2018_SEO
|
Presented By
10:00am to 11:00am
General Admission: $150.00
21+
50 18004479407 UPCOMING EVENTS
PAST EVENTS
Wednesday, August 15th
Online Past Event
|
