Best Practices to Support FDA Computer System Validation

Overview:
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: [email protected]