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Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems
Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems
This seminar will be useful in helping participants understand the finer elements of 21 CFR 11 requirements in CSV.
Fremont,
California,
United States
(sardnews.org)
24/07/2014
Summary: GlobalCompliancePanel will organize a RAPS-preapproved two-day, in-person seminar in Burlingame, CA on the topic, “Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems” on July 24 and 25 (Thursday and Friday). Angela Bazigos, CEO of Touchstone Technologies Silicon Valley, Inc. will be the speaker at this two-day session.
The course, “Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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Venue, date and timings: The venue for this seminar, which will be on July 24 and 25 (Thursday and Friday), from 9 AM to 6 PM EDT, is Hotel DoubleTree by Hilton Hotel San Francisco Airport, 835 Airport Blvd., Burlingame CA 94010-9949.
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What the seminar is about:
This seminar teaches participants how to include 21 CFR 11 requirements in Computer Systems Validation (CSV).
Computer Systems Validation (CSV), also known as Software Validation is critical and all-pervasive in the Life Sciences industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, one needs to really know how to implement CSV, without which it is often very hard to detect the requirement for CSV. This knowledge gap makes it very hard to determine what needs to be done, to meet domestic and/or international regulations or business continuity requirements. Another component that has made this task all the more difficult is that the FDA has stepped up 21 CFR 11 inspections that include CSV.
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About the Speaker:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years’ experience in the Life Sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and conducts classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management.
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For whom:
This seminar will benefit:
o VP of IT
o Director of IT
o Quality Managers
o Project Managers (for CSV/IT)
o Validation Specialists
o Database Administrators
o System Administrators
o Directors/Senior Directors of Discovery
o Directors/Senior Directors of Development
o Directors/Senior Directors of Commercialization
o Document Managers
o Training Managers
This hands-on training session will benefit professionals in the following industries:
o Pharmaceuticals
o Biotech
o Medical Device
o Radiological Health
o Blood Products
o Companion Animals
o Food
o Cosmetics
o Tobacco
o Academia
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About GlobalCompliancePanel:
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX.
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Price:
Register now and save $200. (Early Bird)
Until July 11: Early Bird Price: $1,295.00
From July 12 to July 22: Regular Price: $1,495.00
Discounts are available for group participation in the following manner:
For two attendees: 10% discount
For three to six attendees: 20% discount
For seven to 10 attendees: 25% discount
For more than 10 attendees: 30% discount
To avail the above group discounts, all the participants should register by making a single payment.
Please note that the registration will be closed two days (48 hours) prior to the start date of the seminar.
Call our representative on 1800 447 9407 to have your seats confirmed.
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Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.co
About GlobalCompliancepanel
GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.
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