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:
Computer System Validation (CSV) and the System
Development Life Cycle (SDLC) Methodology
"GxP" - Good Manufacturing, Laboratory and Clinical
Practices
21 CFR Part 11, Electronic Records/Electronic Signatures
(ER/ES)
Data Archival to ensure security, integrity and compliance

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