Practices to Support FDA Computer System Validation


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Tipologia Training
Nível Advanced
Metodologia Online
Duração 1
Início Datas a escolher
Aulas virtuais Sim
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  • Advanced
  • Online
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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

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
21 CFR Part 11, Electronic Records/Electronic Signatures
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


Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

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As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

Informação adicional

Compliance4All DBA NetZealous161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA. Phone: +1-800-447-9407Email: