Practices to Support FDA Computer System Validation

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Category Good Documentation Practices, FDA Validation, FDA compliance standards, Clinical Data Managers, GMP Training Specialists, FDA Compliance Webinars, computer system validation guidelines

Deadline: April 30, 2018 | Date: May 01, 2018

Venue/Country: Online, U.S.A

Updated: 2018-03-20 14:53:58 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com