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2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at Washington DC

Event Details

2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at Washington DC

Time: September 11, 2014 at 9am to September 12, 2014 at 6pm
Location: Hilton Garden Inn Washington DC Downtown
Street: 815 14th St NW, Washington, DC 20005, United States
City/Town: Washington
Website or Map: http://bit.ly/1ntzVHy
Phone: 18004479407
Event Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Organized By: GlobalCompliancePanel
Latest Activity: Aug 6, 2014

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Event Description

The Problem:

Computer Systems Validation (CSV) also known as Software Validation is 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, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.

The Seminar:

This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:

  1. Validation Master Plan
  2. Complete Validation for a System
  3. Excel Spreadsheet Validation
  4. Change Control
  5. SOPs
  6. Test Tools Validation
  7. Project Management for Validation

Who Should Attend?

  • VP of IT
  • Director of IT
  • Quality Managers
  • Project Managers (for CSV / IT)
  • Validation Specialists
  • Database Administrators
  • System Administrators
  • Directors / Senior Directors of Discovery
Industries:
  • Pharmaceuticals
  • Biotech
  • Medical Device
  • Radiological Health
  • Blood Products
  • Companion Animals
  • Food
  • Cosmetics
  • Tobacco
  • Academia

Instructor/Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. 

Date, Time and Venue:

Location: Washington DC

Date: September 11th and 12th, 2014    

Time: 9am to 6pm EDT 
Venue/Hotel: Hilton Garden Inn Washington DC Downtown

Address: 815 14th St NW, Washington, DC 20005, United States

Discount:

Register now and save $200. (Early Bird)

Until July 31, Early Bird Price: $1,295.00

From August 01 to September 09, Regular Price: $1,495.00


Contact Information:

John Robinson

Toll free: 800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

Live Chat - Online Help Desk: http://www.globalcompliancepanel.com/chat/client.php

GlobalCompliancePanel

NetZealous LLC          

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

For More Info on This Seminar Kindly Go through the Link: http://bit.ly/1ntzVHy

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