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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