Practices to Support FDA Computer System Validation
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Website http://www.compliance4all.com/control/w_product/~product_id=501782LIVE?channel=ourglocal_May_2018_SE |
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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
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 Practices21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)Data Archival to ensure security, integrity and complianceWho Will Benefit:Information Technology AnalystsInformation Technology Developers and TestersQC/QA Managers and AnalystsAnalytical ChemistsLaboratory ManagersAutomation AnalystsSpeaker 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$150.00Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supportcompliance4All.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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