Compliance for Computer Systems Regulated by FDA

Start Date : July 13, 2018
End Date : July 13, 2018
Time : 10:00 am to11:30 am

Phone : 800-447-9407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

Website

Description

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

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.

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.




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