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Practices to Support FDA Computer System Validation
Presented By Netzealous LLC DBA - Compliance4All
Tuesday, May 1st at 10:00am PST
Online sale ends: 05/01/18 at 9:00am PST
Online
Fremont, CA 94539
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Description
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 Additional Information
http://www.compliance4all.com/control/w_product/~product_id=501782LIVE?channel=purplepass_May_2018_SEO
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Presented By
10:00am to 11:30am
General Admission: $150.00
50 18004479407 UPCOMING EVENTS
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