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Best Practices to Support FDA Computer System Validation
Tuesday, August 7th at 10:00am PST
Online sale ends: 08/07/18 at 9:00am PST
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Fremont, CA 94539
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We will cover the importance of maintaining the documentation 

from every computer system validation effort in a "current" state. 

The system must be maintained in a validated state throughout its 

entire life cycle, and the accompanying validation documentation 

must also be maintained. 

Why should you Attend:
This session will address the specific way of documenting your 

computer system validation work to ensure it meets FDA 

requirements and can pass an inspection. There are specific 

requirements that must be followed in order for the Agency to 

consider the documentation valid, and without following these, 

there is a great risk of invalidating work.

Areas Covered in the Session:
21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
Data Archival to ensure security, integrity and compliance
Learn the requirements for documenting efforts related to systems 

governed by FDA
Discuss the best practices for documenting computer system 

validation efforts, including requirements, design, development, 

testing and operational maintenance procedures

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

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

Presented By

10:00am to 11:30am
Doors open at 12:00am

General Admission: $150.00

All Ages

Online<br> 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA<br> Fremont, 94539


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