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Practices to Support FDA Computer System Validation


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Who should attend?

QC/QA Managers and Analysts Analytical Chemists Laboratory Managers Automation Analysts

Details

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

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
support@compliance4all.com

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