Compliance for Computer Systems Regulated by FDA

MessageThis Webinar is over
Date Jul 13, 2018
Time 10:00 AM to 11:30 AM
Cost $ 150.00
Online
Overview:
This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.

Why should you Attend:
This Webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.

Areas Covered in the Session:
System Risk Assessment
GAMP 5 "V" Model
21 CFR Part 11
Electronic Records/Electronic Signatures (ER/ES)
Security, Access, Change Control and Audit Trail

Who Will Benefit:
Information Technology Analysts
Information Technology Developers and Testers
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers

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.

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

 


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